attachment 4.8.1 operational reportprocess vessels, lyophiliser, filtration skids, biosafety...

Attachment 4.8.1 Operational ReportIEL Review Application P0005-02Application ID LA001617

MSD Ireland (Brinny)

Project reference: PR-253914Project number: 6053354

01 August 2018

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Attachment 4.8.1 Operational Report Project reference: PR-253914Project number: 6053354Application ID LA001617

Prepared for: MSD Ireland (Brinny) AECOM

Quality information

Prepared by Checked by Approved by

Patricia HowardSenior EnvironmentalConsultant

Caroline DonnellyAssociate Director

Peter Hassett TechnicalDirector

Revision History

Revision Revision date Details Authorized Name Position

1 13 July 2018 Draft PH Peter Hassett TechnicalDirector

2 26 July 2018 Final PH Peter Hassett TechnicalDirector

3 01st August 2018 Revised Final PH Peter Hassett TechnicalDirector

Distribution List

# Hard Copies PDF Required Association / Company Name

0 1 MSD Ireland (Brinny)

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Prepared for:MSD Ireland (Brinny)

Prepared by:Patricia HowardSenior Environmental Consultant

AECOM Ireland Limited4th FloorAdelphi PlazaGeorges Street UpperDun LaoghaireCo. Dublin A96 T927Ireland

T: +353 1 238 3100aecom.com

© AECOM recognises that Merck & Co retains the copyright of this report content, but not theintellectual rights, under the terms of Section 8 to an Engineering, Procurement and ConstructionManagement Master Agreement between Merck & Co and AECOM Technical Services Inc., dated 30th

March 2016.

Where any conclusions and recommendations contained in this Report are based upon informationprovided by others, it has been assumed that all relevant information has been provided by thoseparties and that such information is accurate. Any such information obtained by AECOM has not beenindependently verified by AECOM, unless otherwise stated in the Report. AECOM accepts no liabilityfor any inaccurate conclusions, assumptions or actions taken resulting from any inaccurateinformation supplied to AECOM from others.

The methodology adopted and the sources of information used by AECOM in providing its servicesare outlined in this Report. The work described in this Report was undertaken between May 2018 andJuly 2018 and is based on the conditions encountered and the information available during the saidperiod of time. The scope of this Report and the services are accordingly factually limited by thesecircumstances. AECOM disclaim any undertaking or obligation to advise any person of any change inany matter affecting the Report, which may come or be brought to AECOM’s attention after the date ofthe Report.

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Table of Contents

1. Introduction 12. Description of Plant, Methods and Processes .......................................................................... 2

2.1 Overview ....................................................................................................................... 22.2 Biologics ........................................................................................................................ 32.3 Vaccine Production ........................................................................................................ 42.4 Sterile Manufacturing ..................................................................................................... 52.5 Laboratory Operations ................................................................................................... 62.6 Cleaning Operations ...................................................................................................... 72.7 Process Cooling ............................................................................................................. 72.8 Heat Inactivation ............................................................................................................ 72.9 Heating, Ventilation and Air Conditioning (HVAC) ........................................................... 72.10 Production Automation System ...................................................................................... 72.11 Building Management Systems (BMS) ........................................................................... 82.12 Utilities ........................................................................................................................... 8

3. Aspects of Unit Operations the can cause Emissions to the Environment ................................ 113.1 Emissions during Normal Operations ............................................................................ 113.2 Emissions during a malfunction ..................................................................................... 11

4. Descriptions and Schematics of all Abatement Systems ......................................................... 134.1 Wastewater Treatment Plant (WwTP) ........................................................................... 134.2 Water Scrubber ............................................................................................................ 14

5. Storage Conditions ................................................................................................................ 156. Site Drainage ......................................................................................................................... 16

6.1 Process Drainage ........................................................................................................ 166.2 Storm water Drainage .................................................................................................. 166.3 Foul Drainage .............................................................................................................. 17

7. Main Alternatives ................................................................................................................... 18Appendix A Waste Gas Ammonia Abatement BAT Report ................................................................ 19

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Prepared for: MSD Ireland (Brinny) AECOM1

1. Introduction

MSD Ireland (Brinny) (known throughout this document as MSD Brinny) is applying to the EPA toreview their existing IE Licence (P0005-02) to accommodate three new main emission points to airand an extension of the site operational boundary. These new main emission points are due tochanging manufacturing operations within the MSD Brinny existing Biologics Buildings to permit multi-product fermentation processes. At present the site is restricted to the production of a singlefermentation process within the Biologics buildings. The change mainly involves retrofitting existinginternal building structures to allow for these new processes. The change in site boundary is toaccommodate potential future development at the MSD Brinny site and only includes areas withpreviously granted planning permission.

As the premise for the IEL review is associated mainly with retrofitting existing internal buildingstructures it was agreed between MSD Brinny and the EPA during a pre-consultation meeting in April2018 that the operational report could be limited to a brief site description as environmental conditionson site have not changed significantly since the last Industrial Emissions Licence revision whichoccurred in 2012.

This operational report is presented under the main headings as outlined in the requirements of theEPA’s “Licence Application Form Guidance: Industrial Emissions (IE), Integrated Pollution Control(IPC) and Waste (Issue 1) (2017)”.

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2. Description of Plant, Methods and Processes

2.1 OverviewMSD Brinny is a manufacturing facility for biological based pharmaceutical products, conjugatedvaccine products and sterile manufacturing. The facility operates 24 hours a day, 7 days a week, 365days a year.

A site location map for the MSD Brinny facility is presented in Drawing 001 of this IEL Application andan area layout plan of the MSD Brinny site is shown in Drawing 002. The main features of the facilityinclude:

· Engineering Stores, Boiler House and Utilities (Buildings No. 5, 6 and 7);

· Fermentation (Buildings No. 13 and 18);

· Vaccine Production (Building No. 8 and 21);

· Sterile Manufacturing, Purification Suites 2 & 3 (Building No. 4 and 19);

· Laboratories (Building No. 4, 19 and 22);

· Tech Ops Building (Building No. 22);

· Warehouse (Building No. 13 and 19);

· Offices and Canteen (Buildings 3, 5, 11, 12, 13, 14, 15, 17 and 18);

· Waste storage areas (hazardous and non-hazardous waste storage areas);

· Wastewater Treatment Facilities and Water Treatment Plant; and

· Firewater retention lagoon.

In addition, the following site structures are present; pump houses, cooling towers and chillers,substations, emergency generators, miscellaneous tanks, underground/above ground piping,chemical storage areas and car parks.

MSD Brinny is a manufacturing facility for:

1. Biologics – Fermentation and Purification;

2. Vaccine Conjugation; and

3. Sterile Manufacturing, Formulation and Sterile Fill Finish.

Supporting departments include engineering, laboratories, warehousing and office staff support.

A detailed description of each of these processes is provided in the following sections.

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2.2 BiologicsProcess Flow Diagram No 001 provides an overview of the Biologics Production.

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2.2.1 Fermentation:

The process begins with the thawing of a frozen vial (cryovial) of the working cell bank (WCB) andinoculation of a pre-warmed filter sterilized growth media in pre-sterilized, baffled type, Single-Useflask. The culture is expanded in this shaker flask in a temperature controlled incubator until sufficientcell mass has been produced for the next phase. After the shake flask expansion phase, the culture isaseptically transferred to an expansion (or seed) fermenter where the cell mass is further expandeduntil sufficient for inoculation of the production fermenter.

Following this, the entire culture is transferred to a large fermenter, where it is further expanded. Thefermenter is then operated in either fed-batch or continuous mode with a constant addition of feedsfrom media hold tanks.

2.2.2 Purification:

Following the production phase, the culture is cooled and sent to harvest and depth filtration; a multi-step process involving centrifugation, flocculation, depth filtration and absolute filtration (0.2 µmfiltration). These steps are designed to remove insoluble components such as cells and cell debrisand provide a clarified solution for downstream column purification steps. The product is then furtherpurified using a combination of column chromatography steps which remove host cell impurities,process additives and any product-related impurities.

2.2.3 Fill Finish:

Finally, the product is concentrated and diafiltered by membrane filtration before final concentrationand filling into polycarbonate bottles and freezing. The filled bottles are stored frozen and exported tocustomer/partner sites for labelling and final packaging.

2.3 Vaccine ProductionProcess Flow Diagram No 002 provides an overview of Vaccine Production.

Process Flow Diagram No. 002: Conjugated Vaccines Production

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The vaccine manufacturing process involves the filtration and activation of polysaccharide in additionto filtration of protein, both of which are then conjugated in an aqueous or solvent based carrier.

Upstream size reduction steps, dissolution and preparation of reagents for the conjugation reaction,including lyophilisation, and downstream purification steps are performed at MSD Brinny. Theconjugated product is purified and the bulk product is frozen and stored onsite. The process utilizesprocess vessels, lyophiliser, filtration skids, biosafety cabinets, glove boxes, cold cabinets, a customplatform mixer, temperature control unit (TCU), and various peristaltic pumps, scales, bottle filler andcarts.

2.4 Sterile ManufacturingProcess Flow Diagram No 003 provides an overview of Sterile Manufacturing.

Drug product manufacture takes place in the sterile manufacturing facilities. The drug product isformulated in the compounding area and sterile filtered to the filling line where it is filled into glassvials, fully stoppered (solution products) or semi stoppered (lyophilised products) before beinglyophilised into a powder or left as a solution prior to being capped with an aluminium seal, inspectedand bulk packaged in preparation for transfer to the final packaging sites. . The aseptic manufacturingprocess consists of product compounding, filling, stoppering, lyophilisation (for lyophilised productsonly), capping, inspection and bulk packaging of sterile drug products.

Once capped, the vials are visually inspected, stored under refrigeration and exported tocustomer/partner sites for labelling and final packaging.

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2.5 Laboratory OperationsExtensive quality control laboratories are installed on site to provide testing for all stages ofproduction. The laboratories are divided into four general areas:

· Bioassay;

· Raw Materials;

· Chemistry; and

· Microbiology.

The bioassay laboratories test the potency of intermediates and finished products using cell culturetechniques and measuring the effect of the protein product on cell growth and metabolism.

Raw materials are analysed in chemistry laboratories via standard wet chemistry methods. Processintermediates and finished products are analysed by chemical or biochemical methods such as HighPressure Liquid Chromatography (HPLC), electrophoresis, amino acid sequencing and Enzyme-Linked Immunosorbent Assay (ELISA) techniques. Purified water analysis is also performed.

The microbiology laboratories are primarily concerned with regular monitoring of the microbial qualityof the manufacturing environment and the purified water systems. This involves monitoring of airusing agar settle plates or strips, surface monitoring using agar slabs and water monitoring byfiltration though a bacterially retentive filter. Sterility testing of the finished product is carried out usingsimilar techniques.

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2.6 Cleaning OperationsThe MSD Brinny facility equipment is designed with a clean in place (CIP) / steam in place (SIP)system using validated cleaning procedures.

MSD Brinny is equipped with parts and equipment washing areas separate from the manufacturingareas.

Standard Operating Procedures (SOPs) describe the cleaning and sanitization of manufacturingprocessing rooms. The procedures specify the method and frequency by which each room surface iscleaned by an approved disinfectant. Cleaning activities are recorded on a cleaning log. Alldisinfectants are prepared in accordance with the appropriate SOP. To ensure the effectiveness ofcleaning methods, areas are routinely monitored for microbial contamination using both active air andsurface sampling.

2.7 Process CoolingChilled water is generated through the use of chillers which are maintained via the site preventativemaintenance (PM) programme and also via the site refrigerant management plan.

2.8 Heat InactivationA Genetically Modified Microorganisms (GMMs) inactivation system will be in place to manageprocess waste from GMM cell-containing areas of the new Biologics process. The inactivation systemworks by heating the liquid ≥90°C for 90 seconds retention time followed by cooling to 30°C beforedischarge to the inactivation sump followed by pumping to the WwTP. This is to comply with GMMlicence number G0003-02 as per the Genetically Modified Organisms (Contained Use) Regulations2001 to 2010. As per the aforementioned regulations the existing and proposed cell lines are Class 1(activities of no or negligible risk).

2.9 Heating, Ventilation and Air Conditioning (HVAC)The site HVAC system provides environmentally-controlled air for the facility. This involvesmaintaining air at predetermined pressures, temperatures and humidity levels, as required by area.

2.10 Production Automation SystemThe MSD Brinny control systems that control and monitor qualified process functions consists ofDistributed Control Systems (DCS), Programmable Logic Controllers (PLC’s), Supervisory, Controland Data Acquisition Systems (SCADA’s) as well as automated equipment. These systems controlEngineering and Manufacturing process systems.

The control systems monitor and control product production and qualified process1 utilities. Thesesystems utilise operator stations, servers, Ethernet communications, PLCs and distributed controllersto perform continuous and batch control of production.

These systems operate in conjunction with vendor control systems (PLCs) located on processpackaged equipment skids. In general, these systems provide a single control system hardware andsoftware platform for validated process systems including stick-built equipment and equipment skids.For process equipment, data collection / historian functionality is provided via DCS, SCADA, chartrecorders or specialised data historians.

The control systems provide an interface for real time operator interaction with the process. Thesystems perform continuous, regulatory and discrete control logic, basic sequential logic, batchoperations, recipe execution, historical trending, event recording, and generate printed reports. Thesystems provide security levels with varying degrees of system access.

1 A ‘qualified process’ is one that must consistently and repeatedly meet specified good manufacturing practice (GMP)standards to protect human health. Such processes must undergo specific and detailed qualification and validation steps.

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The selected systems also support future integration of an MES (Manufacturing Execution System), aholistic computerised system used to track drug substance production through from raw materials tofinal product.

2.11 Building Management Systems (BMS)Two separate Building Management Systems (BMS) are installed to control and monitor bothQualified (Q) and Non-Qualified (NQ) building services and utility systems as follows:

1. QBMS (Qualified Building Management System): The QBMS is used to monitor and controlqualified HVAC systems and monitor specific qualified equipment. QBMS has OperatorInterfaces located in Manufacturing, the Warehouse and the Laboratory/Administration Building.

2. NQBMS (Non-Qualified Building Management System): the NQBMS is used to monitor andcontrol both non-qualified HVAC systems and nonqualified plant utilities. NQBMS has OperatorInterfaces located in Manufacturing, the Warehouse, Utilities buildings and the Laboratory/Administration Building.

3. There are also a number of separate stand-alone BMS systems monitoring HVAC in other areas.

2.12 Utilities

2.12.1 Plant Steam

There are three natural-gas boilers (with a maximum combined output of 33,000 kg/hr) on site whoseoutput of steam is distributed throughout the site to various production buildings and associatedcondensate collection systems. MSD Brinny has a Greenhouse Gas Permit (Permit No. IE-GHG018-10248-3).

2.12.2 Combined Heat & Power Plant

The CHP plant comprises two main items of plant equipment: an electricity generator and a steamboiler, and related installation as follows:

a. 4.6MWe Natural Gas fuelled Gas Turbine powered generator set;

b. 6 T/hr Waste Heat Recovery Steam Boiler (WHRB);

c. 1300kW Waste Heat Recovery Water Heater; and

d. Ancillary equipment including gas, water and steam piping, electrical switchgear and controlsystems.

The CHP plant generates approximately 40% of site electricity usage and Low Pressure Hot Water(LPHW).

2.12.3 Water for Processing and Potable Use

Water is obtained from three groundwater wells on site and is used for production processes on site.The groundwater is first treated in a decarbonator unit. From here it is pumped to the productionbuildings where the water receives further treatment in Reverse Osmosis water treatment plantlocated within each building. Water used in production is mainly for the generation of Water forInjection (WFI). A number of water systems require chemical dosing to prevent corrosion andminimise bacterial build up. These include:

· The Low Temperature Hot Water (LTHW) Boiler System and

· The HVAC Chiller Water Loops.

Water for potable use is obtained from three on-site groundwater wells which undergo treatment withpH correction with Lime and Chlorination utilizing sodium hypochlorite.

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2.12.4 Water For Injection (WFI)

WFI is required for make-up of process inputs i.e. filling, media and buffer solutions, laboratories andcleaning operations. This high purity water is prepared by feeding reverse osmosis treated water tomulti effect still units. The WFI is stored and distributed to all locations requiring WFI, including theCIP systems as well as the buffer and media solution preparation areas.

2.12.5 Clean Steam

Clean steam is employed for the sterilisation of process equipment. It is produced from the distillationof reverse osmosis water in the clean steam generator.

2.12.6 Clean Gases (Nitrogen, Oxygen, Argon, Carbon Dioxide) and Liquid Nitrogen

Nitrogen, Oxygen and Carbon Dioxide gases are used to control the environment within productionequipment as well as back up supply for cryogenic freezers. Argon is used in the site laboratories. Thegases are supplied from liquefied gas storage vessels.

2.12.7 Chilled Water

Chilled water is generated through the use of dedicated duty/standby chillers.

2.12.8 Low Pressure Hot Water

Low Pressure Hot Water is generated through the use of plant steam/water heat exchangers.

2.12.9 Cooling Towers

There are four cooling towers on site with associated distribution pumps, piping, fans, filtration andchemical treatment systems.

2.12.10 Process Cooling Water

Existing chilled process cooling consists of a primary circuit of Ammonia plants supplying a buffer tankwith secondary glycol circuits at various temperatures. The glycol circuits supplying productionbuilding primarily used in cooling jackets for vessels and equipment all of these circuits are closedloop.

2.12.11 Generator Compound

There are a total of four diesel fuelled emergency generators present on site to provide backup powerin the event of mains electricity failure.

2.12.12 Process Air

Clean compressed air is prepared by compression and subsequent drying and filtration of air..

2.12.13 Compressed Air

A centralised compressed air system is in operation in Building 4. The system comprises ofcompressors and desiccant dryers followed by filtration and pressure reduction which is then split intoseparate Instrument and Process air systems.

2.12.14 Firefighting water

There are two on site water storage tanks each maintained at a level to provide a capacity of 1000 m3

of firewater. Each tank is supplied by a network of three groundwater wells to provide re-charge to thetanks at a rate of 150 m3/hour. Each tank is connected to a duty/standby pump set designedcollectively to deliver up to 18,924 litres/minute of firewater to the ring main system. The pump sets

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feed a private underground 250mm ring main system. The ring main also supplies hydrants locatedaround the site.

2.12.15 Electricity

The site has an existing 10 kV capacity.

2.12.16 Gas Supply

An existing gas main serves the MSD Brinny site.

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3. Aspects of Unit Operations the can cause Emissions to the

Environment

3.1 Emissions during Normal OperationsDuring normal day to day site operations the following scheduled emissions take place:

1. One boiler normally operates on duty with the remaining two on standby. The steam boilersoperate on natural gas in normal day to day conditions in accordance with Schedule B.1 of thesite IEL.

2. A new main emission point (A2-1) is proposed for the Biologics expansion at MSD Brinny. Priorto discharge, the proposed ammonia waste gases will be treated via a water scrubber. Asoutlined in Attachment 7.1.3.2 the impact associated with this new main emission point isinsignificant and will comply with the ELV set by the EPA.

3. As part of this IEL review application MSD Brinny are including a provision for two possible futuremain emissions points to atmosphere (to be referenced as A2-2 and A2-3), which will be locatedin the vicinity of Building 18. At this stage, there are no planned emissions from these points andshould MSD Brinny plan on using either of these main emission points in the future, a TechnicalAmendment will be submitted to the EPA along with, if necessary, dispersion modelling of actualemissions. .

4. Minor emissions to atmosphere occur during normal day to day conditions as discussed inAttachment 7.4.2 of this IEL review Application.

5. Fugitive emissions to atmosphere occur during normal day to day conditions as discussed inAttachment 7.4.2 of this IEL review Application.

6. Treated wastewater is discharged from the site WwTP as per Condition B.2 of the site IEL.

7. Storm water discharges from the site within set trigger values for pH, temperature and TotalOrganic Carbon as were agreed with the EPA in August 2016.

8. The day to day operation of the site results in noise emissions which are in compliance withSchedule B.4 of the site IEL.

9. Short term fugitive emissions may arise from the filling of the diesel tank on site (adjacent to thesite Utilities building and the firewater pump diesel tank).

10. Short term emissions to atmosphere will arise from the routine testing of the site generators.This test takes place once a month for a 90 minute period.

Drawing 005 of this IEL Review Application outlines the various monitoring points across the MSDBrinny site.

3.2 Emissions during a malfunctionIn the event of a loss of power to the site the four emergency generators will maintain essential siteservices. Emissions from the generators during such an event would comprise short term emissionsof nitrogen oxides (NOx), oxides of sulphur (SOx), carbon monoxide (CO) and particulate matter 10micron (PM10). A loss of mains power to the site would result in a closure of the WwTP pumpingmechanism until the site generators become operational. Adequate storage capacity is provided tocollect any effluent (process and foul) generated for 24 hours after the power failure.

There is a storm water monitoring chamber located to the far south of the MSD Brinny production site.The chamber includes a continuous monitoring system for pH, temperature and Total Organic Carbonwhich is connected to and monitored by the SCADA in the WwTP Control Room. The monitoringsystem controls a motorized valve in the flow chamber located near the retention lagoon. Should themonitoring system detect contamination, the flow is diverted from the receiving water (initially theRiver Brinny but ultimately the Upper Bandon Estuary) to the lined retention lagoon. From the lagoon,

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contaminated water can be assessed and tested and either pumped back to the WwTP or removedfrom the lagoon for off-site recovery or disposal.

Other emissions which may occur during a malfunction include:

· Rupturing of burst discs could result potential vapour emissions to atmosphere; and

· Seal failures in the chiller units could result in emissions to atmosphere of refrigerants.

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4. Descriptions and Schematics of all Abatement Systems

4.1 Wastewater Treatment Plant (WwTP)Process Flow Diagram No 004 provides an overview of the on-site WwTP. The WwTP has remainedrelatively unchanged since the 2012 Licence Application.

Process wastewater is pumped to one of two holding cells. The two cells equalises temperature, pH,and nutrient concentrations. Sanitary wastewater from MSD Brinny is mixed with the processwastewater downstream of the holding cells. The combined stream is then directed to a ‘splitter’where the flow is split for subsequent biological treatment via activated sludge. The bulk of thewastewater leaving the splitter is fed to the anoxic tank where nitrates and nitrites are converted tonitrogen gas. A smaller stream from the splitter is mixed with return activated sludge (RAS) beforealso entering the anoxic tank. From the anoxic tank, the wastewater flows to the aerobic tank whereair bubbling through from the bottom converts ammonia to nitrates and nitrites. Organic molecules are

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degraded in both the anoxic and aerobic tanks; they provide the carbon and nutrient sources for theactivated sludge microorganisms to grow. Some wastewater is recirculated from the aerobic tank backto the anoxic tank, while some leaves the aerobic tank to a gravity settling clarifier. The activatedsludge falls to the bottom of the clarifier with a solids content of approximately 1% by mass leaving alayer of treated wastewater at the top.

The treated wastewater is fed to a final effluent tank where it can be released to the Bandon Estuaryat all times except for the 45 minutes on either side of high and low tide (as set out in Condition 5.5 ofthe site IEL). The final pumping rate is currently limited to 50m3/hr. However as outlined inAttachment 7.2.1 of this IEL review MSD Brinny are requesting this rate be increased to 70m3/hrwhich will allow the site some degree of flexibility while still maintaining their Maximum Daily Limit of800m3 and also adherence to Condition 5.5 of their IE Licence.

Some of the activated sludge at the bottom of the clarifier is returned to the biological treatment,where untreated process and sanitary waste from the splitter feed the RAS before it enters the anoxictank. The rest of the activated sludge from the bottom of the clarifier gets dewatered by a decanter,which concentrates the sludge to approximately 18% solids. The dewatered sludge is trucked off theMSD Brinny site for disposal to a licensed waste facility.

Currently, MSD Brinny’s wastewater is lacking in carbon. Molasses is supplemented to thewastewater to increase the biochemical oxygen demand (BOD), which is an indirect measurement ofthe nutrients in the wastewater.

4.2 Water ScrubberDue to the new Biologics Process planned for MSD Brinny a water based scrubber is being installedto treat waste gases containing ammonia before discharge to atmosphere. Appendix A of this reportentitled ‘Waste Gas Ammonia Abatement – BAT Report’ describes the proposed abatement for thetreatment of waste ammonia gas.

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5. Storage Conditions

Raw materials and supplies are delivered to site by contractors/vendors. Storage of raw materialsand supplies largely takes place in the main site warehouse but also at the following designatedareas:

· Engineering Stores

· Building 8

· Building 13 Warehouse

· Building 22

· Building 21 Staging warehouse

· Gas cylinder store

· Dedicated and bunded bulk storage tanks ((Sulphur Free Gas Oil), HCL, Sodium Hydroxide,Phosphoric acid and glucose syrup)

· Dedicated chemical storage cabinets

· Nitrogen and oxygen bulk gas storage tanks

· Solvent store

In accordance with conditions 3.6 and 8.4 of the site’s IEL storage of materials only takes place indesignated areas. All fixed and mobile storage tanks are surrounded by contained bunds (110%capacity) that are designed to contain material in the event of spill. Loading and unloading ofmaterials takes place only in designated areas. All bunds are integrity tested every three years inaccordance with the requirements of the IEL. Details of such testing are reported annually to the EPAand detailed rest records are maintained on site.

Storage areas on site are highlighted in Drawing No.007.

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6. Site Drainage

Drawing No.003 depicts the site drainage network. In accordance with condition 6.9 of the site’s IELunderground pipework is integrity tested every three years. Details of such testing are reportedannually to the EPA and detailed test records are maintained on site.

6.1 Process DrainageEach process building is connected to an underground drainage network which is connected to thesite WwTP for treatment prior to discharge (at Emission Point Code SW1-D) via a 9km pipeline to theUpper Bandon Estuary approximately 700m north of Kilmacsimon. The pipeline is buried and followslocal roads in a southerly direction from the site. The pipe passes under the road through Innishannonvillage and crosses the Bandon River via Innishannon Bridge. The pipe continues in a southerlydirection, following the course of the Bandon River and then into the estuary at Colliers Quay (SW1-D). At this point it is laid on the surface of the intertidal area of the estuary on concrete footings for2km. During low tide sections of the pipeline are visible. The final approximately 30m of the pipe islocated towards the centre of the estuary channel and the outfall point is always submerged. There isa diffuser system at the outfall which helps disperse the treated effluent.

The highest point on the route is approximately 2km from the plant. Two pumps are used to pump thetreated effluent to this point. When the pumps are on the pumping pressure results in the effluentflowing in the pipe at greater velocity than when the pumps are off. When the pump is switched off theeffluent remaining in the pipe beyond the highest point drains down under gravity to the outfalldiffuser. There are non-return valves that prevent the pumped effluent flowing back to the WwTP.

6.2 Storm water DrainageAll surface water runoff from non-process areas of the site i.e. roofs, roads, car parks and pavedareas is collected in the site storm water drainage network. There are two Class I Oil Interceptors onthe storm water drainage network at the following locations:

· Yard 1: Diesel oil truck loading area for diesel tanks, for steam boilers and standby generators.

· Yard 2: Stand-by generator and warehouse delivery standing yard.

The Class I oil Interceptors have high oil level alarm probes which if alarmed will activate at theSCADA in the WwTP Control Room and also have a local beacon alarm.

There are six Class II Oil Interceptors on the storm water drainage network at the following locations:

· South end of the site known as the final interceptor

· Yard 2 (the stand-by generator and warehouse delivery standing yard)

· Building 8

· Main car park

· Southern end of the contractor’s compound.

· Building 21 car park

There is a storm water monitoring chamber located to the far south of the MSD Brinny production site(Emission Point Code SE1-M). The chamber includes a continuous monitoring system for pH,temperature and Total Organic Carbon which is connected to and monitored by the SCADA in theWwTP Control Room. The monitoring system controls a motorized valve in the flow chamber locatednear the retention lagoon. Should the monitoring system detect contamination, the flow is divertedfrom the receiving water (River Brinny and ultimately Upper Bandon Estuary) to the lined lagoon.Trigger values for continuous monitoring were agreed with the EPA in August 2016. .

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6.3 Foul DrainageFoul effluent from welfare facilities on site drain via a gravity sewer network to the site WwTP.

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7. Main Alternatives

The reason for this IE Licence review is to expand Biologics operations at MSD Brinny. Theseoperations due to their complex nature do not have many alternatives. MSD Brinny is alreadyundertaking these processes and has an excellent IE Licence compliance track record.

An assessment of alternative ammonia abatement technologies was undertaken. Appendix A of thisreport entitled ‘Waste Gas Ammonia Abatement – BAT Report’ describes the alternatives consideredfor the treatment of waste ammonia gas.

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Appendix A Waste Gas Ammonia Abatement BAT Report

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Issue date: 12 December 2017

Waste Gas Ammonia Abatement - BAT Report

MSD Brinny Project Lion IE0311878-22-RP-0002, Issue: A

Customer Project Number: RFC 4192

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162.TP.09, Issue 7, 31/03/2014 Formal Issue

Document Sign Off

Waste Gas Ammonia Abatement - BAT Report

MSD Brinny Project Lion IE0311878-22-RP-0002, Issue A

Customer Project Number: RFC 4192

File No: IE0311878.22.160

CURRENT ISSUE

Issue No: A Date: 13/12/17 Reason for issue: For IE Licence Compliance

Sign Off Originator Checker Reviewer Approver Customer Approval (if required)

Print Name Frank Buckley N/A Brian Tiernan Robert Giltinan

Signature Authorised Electronically

Date 13/12/2017 13/12/2017 13/12/2017

PREVIOUS ISSUES

Issue No

Date Originator Checker Reviewer Approver Customer Reason for issue

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MSD BrinnyProject Lion

IE0311878-22-RP-0002, Issue A13/12/2017

IE0311878-22-RP-0002_A_01.DOCX Page 3 of 27 Formal Issue

Contents

1 Executive Summary 4

2 Introduction 5

3 Environmental and Regulatory Considerations 6

3.1 Interpreting BAT 6

3.2 Other Applicable Legislation and Guidance 8

4 Screening Assessment of Ammonia Treatment Systems 11

4.1 Potential Technologies 11

4.2 Overview of Scrubbing Technologies 12

5 Assessment of Ammonia Treatment Systems 13

5.1 Emission Details 13

5.2 Impacts Quantification 14

5.3 Comparison of Environmental Impacts between Options 15

5.4 Resolution of Cross Media Effects 15

5.5 BREF Documents/ ‘BAT Conclusions’ Assessment 16

6 Conclusions 27

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1 Executive Summary

Due to the introduction of a new multi-product fermentation installation in MSD Brinny there is a requirement to treat waste gases containing ammonia before they are discharged to the atmosphere. These waste gases originate from a 450 litre holding vessel (vessel tag number TK- 582) containing 25% w/w ammonium hydroxide solution.

This document outlines a Best Available Techniques (BAT) assessment of appropriate ammonia abatement technologies taking into account process specific requirements. The main conclusions of this assessment are that:

- Both water and acid scrubber units represent BAT for the specific application;

- Given the requirement to use hazardous sulphuric acid solution with the acid scrubber and the related process safety issues in its use and subsequent disposal, the water scrubber is regarded as the better technology option.

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2 Introduction

MSD Brinny operates under an Industrial Emission Licence (Licence No. P0005-02), granted by the Environmental Protection Agency, in compliance with the Industrial Emissions Directive (2010/75/EU). The licensed class of activity for the site relates to the production of pharmaceutical products.

A new multi-product fermentation installation centred on a 20,000 litre fermenter and associated downstream harvesting (Centrifuging, Depth and Absolute filtration) and purification (Chromatography, Ultra and Dia filtration) is being designed and installed at the site (project referred to as Project Lion). As part of fermentation operations 25% w/w ammonium hydroxide solution is added to the 20,000 litre fermenter on a batch basis from a 450 litre holding vessel (TK- 582) primarily for pH control. The vessel is pressurised with air to facilitate flow control into the fermenter. Abatement technology will treat any ammonia present in the vent line from this 450 litre holding vessel before discharging to atmosphere. The vent stream occurs as part of the normal pressure-control scheme, or at the end of the batch during depressurisation.

Under the Industrial Emissions Directive (2010/75/EU), operators must demonstrate that their operations cause no significant pollution and that they represent Best Available Techniques (BAT) in the prevention and minimisation of pollution.

The purpose of this document is to undertake a BAT assessment of appropriate ammonia abatement technologies and subsequently provide justification for the chosen technology taking into account the process specific requirements.

The BAT assessment is carried out in three stages:

The first stage of the assessment provides background information on BAT, an interpretation of its definition, its applicability to industries and how it should be used during a technology selection process. Other specific information taken into consideration during the BAT assessment is also outlined, i.e. relevant legislation and guidance regarding emission limits values of ammonia.

The second stage entails a BAT screening exercise on the potential technology options for the treatment of ammonia emissions in air. This takes into account the flow characteristic of the ammonia exhaust to be treated, the efficiency of the method and any process incompatibilities with the method.

The final stage involves a BAT assessment of the selected option(s) and justification of same using the relevant BAT Reference (BREF) document and BAT Conclusions where applicable.

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3 Environmental and Regulatory Considerations

- Interpreting BAT

BAT is intended to assist in identifying techniques that are the best for the environment as a whole, and that are economically and technically viable for an activity.

The term ‘best available techniques’ is defined in Article 3(10) of the Industrial Emissions Directive as the most effective and advanced stage in the development of activities and their methods of operation which indicates the practical suitability of particular techniques for providing the basis for emission limit values and other permit conditions designed to prevent and, where that is not practicable, to reduce emissions and the impact on the environment as a whole.

According to Article 15 (4) of the Industrial Emissions Directive, these emission limit values, equivalent parameters and technical measures must, without prejudice to compliance with environmental quality standards, be based on the best available techniques, without prescribing the use of any technique or specific technology, but taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions.

In summary BAT means all techniques, including technology, planning, construction, maintenance, operation and decommissioning, which are applicable in practice under acceptable technical and economic conditions and are the most effective for the provision of a high level of protection for the environment as a whole.

In accordance with Article 13 of the IED the Commission organises an exchange of information between Member States and the industries concerned on BAT, associated monitoring and the developments in them. This is carried out by the relevant Technical Working Groups in the European IPPC Bureau in Seville, who issue a series of BREFs in conjunction with regulators and industry groups. These do provide conclusions on techniques associated with BAT and Emission Values associated with BAT (BATAELs), but it is important to stress that BREFs have no legal basis and are neither site specific nor prescriptive, indeed as Section 5 of the preface to the BREF document for the Manufacture of Organic Fine Chemicals, Aug 2006 clarifies:

The determination of appropriate permit conditions involves taking account of local, site-specific factors such as the technical characteristics of the installation concerned, its geographical location and the local environmental conditions. In the case of existing installations, the economic and technical viability of upgrading them also needs to be taken into account. Even the single objective of ensuring a high level of protection for the environment as a whole will often involve making trade-off judgements between different types of environmental impact, and these judgements will often be influenced by local considerations.

Geographical situations and local conditions vary widely throughout the EU, from an area dense in industrial facilities, with a resulting high level of emissions, to more rural areas with little or no industrial facilities and hence a relatively low emissions burden. There is also the issue of financial cost, which clearly is addressed in the definition of BAT above.

Article 14 (5) of the IED points out that where the competent authority sets permit conditions on the basis of a BAT not described in any of the relevant BAT conclusions, it shall ensure that the technique is determined by giving special consideration to the criteria listed in Annex III of the IED, repeated as follows:

- the nature, effects and volume of the emissions concerned;

- the use of low waste technology;

- the use of less hazardous substances;

- the furthering of recovery and recycling of substances generated and used in the process and of waste where appropriate;

- comparable processes, facilities or methods of operation, which have been tried with success on an industrial scale;

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- technological advances and changes in scientific knowledge and understanding;

- the nature, effects and volume of the emissions concerned;

- the commissioning dates for new or existing activities;

- the length of time needed to introduce the best available techniques;

- the consumption and nature of raw materials (including water) used in the process and their energy efficiency;

- the need to prevent or reduce to a minimum the overall impact of the emissions on the environment and the risks to it;

- the need to prevent accidents and to minimise the consequences for the environment, and;

- information published by public international organisations

Therefore the overriding objective in any BAT consideration is to prevent damaging releases or to reduce releases as far as possible, taking into consideration costs and advantages. The actual cost of applying a technique will depend strongly on the specific situation regarding, for example, taxes, fees and the technical characteristics of the installation concerned.

An important principle of EU Legislation, including that of environmental protection, is the Principle of Proportionality, which requires that the extent of the action must be in keeping with the aim pursued. When applying the general principle of proportionality, the European Court of Justice frequently states that the principle requires an act or measure to be “suitable” to achieve the aims pursued, or it rather concludes that a decision is disproportionate because it is “manifestly inappropriate in terms of the objective which the competent institution is seeking to pursue”.

Where there are several options it is conceptually possible to plot a curve of cost against environmental benefit. With three or more points it may be possible to identify the point, after which, the cost of abatement increases significantly.

From a technical perspective this can be illustrated by the graph below, taken from UK Environment Agency H1 Horizontal Guidance on Environmental Risk Assessment (Annex K – Cost Benefit Analysis): Figure 3.1 – Marginal Cost of Abatement.

One would be required to invest in techniques reflected by position A, where techniques are defined as both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned. However, at point B the cost per mass of pollutant avoided starts to rise rapidly and under normal circumstances an operator would not be required to invest in the high cost techniques reflected by position C, i.e. it would not be proportionate. This whole approach is formalised in the EU Reference Document on Economics and Cross Media Effects, July 2006.

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- Other Applicable Legislation and Guidance

3.2.1 EU Legislation and International Agreements

Ammonia environmental impacts relate to the formation of aersol particulate matter and eutrophication. National emission ceiling limits for ammonia (NH3) are regulated under the EU National Emissions Ceiling (NEC) Directive (2001/81/EC) and the Gothenburg protocol under the United Nations Convention on Long-Range Transboundary Air Pollution. The NEC Directive is transposed into Irish Law by European Communities (National Emission Ceilings) Regulations, 2004 & 2012 (S.I. 10 of 2004 and S.I. 303 of 2012) and specifies an NH3 ceiling limit of 116 kt. The NEC Directive will be repealed and replaced by Directive 2016/2284/EU in June 2018 which amends Ireland’s NH3 ceiling limit to a 1% reduction by 2020 and a 5% reduction for 2030 (based on a 2005 baseline). Environmental quality standard limits for NH3 have been specified by a Working Group of the UN Convention on Long-Range Transboundary Air Pollution (UNCLRTAP)1. Refer to Table 1 for these annual mean environmental quality standard values.

Table 1 – Ammonia Environmental Quality Standard Limits (UNCLRTAP)

Ammonia Concentration – Critical Level*

(µg/m3)

Averaging Period Applies To

1 Annual mean Sensitive lichen communities & bryophytes and ecosystems where lichens & bryophytes are an important part of the ecosystem’s integrity

3 Annual mean For all higher plants (all other ecosystems)

*.“Critical level means concentrations of pollutants in the atmosphere above which direct adverse effects on receptors, such as human beings, plants, ecosystems or materials, may occur, according to present knowledge”

3.2.2 UK Environment Agency Environmental Assessment Levels

The UK Department for Environment, Food and Rural Affairs (DEFRA)2 has specified both annual and hourly environmental assessment levels for ammonia, as outlined in Table 2 overleaf.

1 UN ECE Convention on Long-range Transboundary Air Pollution (2007): Report on the Workshop on Atmospheric Ammonia:

Detecting Emission Changes and Environmental Impacts, Report No. ECE/EB.AIR/WG.5/2007/3 2

UK DEFRA (2016). ‘Air Emissions risk assessment for your environmental permit’. Accessed Dec 2017. Available at: https://www.gov.uk/guidance/air-emissions-risk-assessment-for-your-environmental-permit

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Table 2 – UK DEFRA Ammonia Environmental Assessment Levels

Environmental Assessment Level

(µg/m3)

Averaging Period

180 Annual limit

2,500 Hourly limit

3.2.3 Odour Assessment Levels Guidance

Ammonia is also an odorous compound with odour detection levels ranging from 5 to 53 ppm3. The odour impact of ammonia at varying concentration levels4 is described in Table 3.

Table 3 – Ammonia concentration and corresponding odour effect

Ammonia Concentration (ppm)

Odour effect 4

5 “Scarcely detectable and not at all annoying”

10 “Noticeable, but only mildly”

20 “Distinct, but not very annoying”

Odour related guidance documents, such as the Environment Agency of England and Wales (EA) H4 Horizontal guidance note ‘Odour Management’5 and the ‘Odour Guidance 2010’ developed by the Scottish Environmental Protection Agency (SEPA)6 address odour and the requirements of the adjacent population for a good quality of life.

The mere presence of an odour does not necessarily mean that it is offensive. The characteristics of an odour that are taken into account when assessing its offensiveness are Frequency, Intensity, Duration, Odour Unpleasantness, and Location; sometimes described by the acronym FIDOL6.

The SEPA Guidance note for Odour, ‘Odour Guidance 2010’ sets out the criteria for the various types of odours and their perceived thresholds for odour unpleasantness and intensity as per Table 4.

The criterion sets the odour threshold used for facilities which should be met at the nearest sensitive receptor.

Local factors may influence these limits. The SEPA guidance document stipulates that if the local population has already become sensitised, it may be prudent to reduce the threshold by 0.5 OUE/m3.

3 (US) National Research Council (2008). “Acute Exposure Guideline Level for Selected Airborne Chemicals: Volume 6”, Available at:

https://www.ncbi.nlm.nih.gov/books/NBK207883/ 4

FM Global (2012). “Property Loss Prevention Data Sheets – 7-13, Mechanical Refrigeration”, pg. 13

5 Environment Agency of England and Wales (EA) H4 Horizontal Guidance Note ‘Odour Management How to comply with your environmental permit’

6 Scottish Environmental Protection Agency (SEPA) Guidance Note for Odour, ‘Odour Guidance 2010’

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Table 4 - Industrial Activities and Indicative Criteria of Significant Pollution (Note 1) (Source: Odour Guidance 2010, SEPA)

Technique Indicative criterion of significant pollution Note 2

More offensive odours: Activities involving putrescible wastes Processes involving animals or fish remains Brickworks Creamery Fat & Grease Processing Waste water treatment Oil refining Livestock feed Factory

1.5 OUE/m3 (1.0 OUE/m3)Note 3

Odours which do not obviously fall within a high or low category: Intensive Livestock rearing Fat Frying (food processing) Sugar Beet Processing

3 OUE/m3 (2.5 OUE/m3)Note 3

Less offensive odours (but not inoffensive) Chocolate Manufacture Brewery Confectionary Fragrance and Flavourings Coffee Roasting Bakery

6 OUE/m3 (5.5 OUE/m3)Note 3

Note 1: Reference EA H4 Guidance Appendix 6 Note 2: Odour units (OUE) as 98th percentile of hourly averages Note 3: Local adjustment for hypersensitive populations (odour generated a high level of complaint) – Reference: EA H4 Guidance Appendix 6

It is assumed that the odour from ammonia falls into the “More offensive odour” category.

3.2.4 Occupational Exposure Limit Values for Ammonia

Ammonia is a toxic material and poses a risk to human health as well as the environment above various time-averaged concentration limit values. The occupational exposure limit values for ammonia shown in Table 5 below are taken from ‘2016 Code of Practice for the Chemical Agents Regulation’ produced by the Health and Safety Authority. While these are not directly related to the environmental impact assessment beyond the site boundary they inform the required odour abatement ammonia concentration.

Table 5 – Ammonia Occupational Exposure Limit Values

Occupational Exposure Limit Value Type

OEL Value (ppm)

Exposure Time

Short Term Exposure Limit 50 15 min

Long Term Exposure Limit 20 8 hr

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4 Screening Assessment of Ammonia Treatment Systems

4.1 Potential Technologies The ‘BAT Reference Document for Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector, Industrial Emissions Directive 2010/75/EU, 2016’ outlines the potential treatment technologies for the removal of ammonia from waste gas. Table 3.147 of this document lists the potential ammonia treatment technologies detailed in Table 6 below:

Table 6 – Waste Gas Treatment Techniques for the removal of ammonia (from BREF for Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector, Table 3.147)

Technique Abatement efficiency

Condenser 80-90%

Adsorption (Zeolites) 80-95%*

Wet gas scrubber > 99%

Acid gas scrubber > 99%

Biofiltration 70-99%*

Bioscrubbing 80-95%

Biotrickling 80-95%

Photo/UV oxidation < 98%

*.Specific abatement efficiency for ammonia was not explicitly stated for Adsorption (Zeolites) or Biofiltration techniques. The abatement efficiency used in the table relates to that for odour.

The required abatement efficiency and exhaust gas flowrate range determine the applicability of the above techniques. The exhaust gas flowrate range (1 to 20 Nm3/hr, with max flow limited by a flow orifice) to the abatement system, is relatively low. To avoid any odour issues associated with the treated exhaust from the abatement system a high abatement efficiency (>99%) is required. Further details on the exhaust gas stream to the abatement unit are outlined in Section 5.1.1. The treatment techniques of Condensation, Adsorption (Zeolites), Bioscrubbing, Biotrickling and Photo/UV oxidation are excluded due to the maximum abatement efficiency possible with these techniques being below what is required. The abatement efficiency outlined for Biofiltration relates to odour and may be lower for ammonia. The typical flowrates treated by this technology are in the range of 100 to 200,000 Nm3/hr, which is well in excess of the exhaust gas flowrates requiring treatment and is also therefore excluded.

The two techniques that are therefore selected for further assessment are:

- Wet (Water based) gas scrubber

- Acid gas scrubber

Both these techniques are suitable for the required exhaust flowrates to be treated and provide abatement efficiencies greater than 99%.

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4.2 Overview of Scrubbing Technologies Wet scrubbing (or absorption) is a mass transfer operation between a soluble gas and a solvent – often water – in contact with each other. The compound to be removed from the waste gas stream is dissolved in the absorbing liquid thereby allowing the recovery of the gaseous compound7.

The various types of scrubbers available are:

- Fibrous packing scrubbers

- Moving-bed scrubbers

- Packed bed scrubbers

- Impingement plate scrubbers

- Spray towers

The type of scrubber deemed most appropriate for the specific waste gas streams generated from Project Lion process is a packed bed scrubber (vendor specified). Packed-bed scrubbers consist of an outer shell containing a bed of variously shaped packing material on support grids, liquid distributors, gas and liquid inlets and outlets and a mist eliminator. In vertical designs (packed towers), the gas stream flows up the chamber (countercurrent to the liquid). A schematic of this type of scrubber is shown in Figure 1.

For the relatively low gas flowrates in question, a once through scrubber configuration is regarded as the best option.

Figure 1 Schematic of a typical packed bed scrubber system (taken from Pollution Abatement Technology for Particulate and Trace Gas Removal, Her Majesty’s Inspectorate of Pollution, Bristol, 1994 as reporduced in BREF for Common Waste Water and Waste Gas Treatment/Management Systems in the Chemical Sector, Industrial Emissions Directive 2010/75/EU, 2016) (NOTE 1: Demister is not present in srubber proposed for Project Lion as carry-over of droplets/mist is not considered to be problematic)

A water scrubber is used for the removal of compounds that are easily dissolvable in water, such as ammonia. Acid scrubbers are used to remove alkaline compounds, which also include ammonia. The dosing of the acid is done by means of pH regulation. The pH is generally kept between 3 and 6. Sulphuric acid is usually selected as the acid of choice due to economic reasons.

7 Ullmann’s ‘Air, 7. Waste Gases, Separation and Purification’, Ullmann’s Encyclopedia of Industrial Chemistry (7th

edition, electronic release), 2012.

(NOTE 1)

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5 Assessment of Ammonia Treatment Systems

In this section a BAT assessment is carried out on the remaining two potential technology options of a water and acid scrubber for ammonia abatement. This assessment involves:

1. Quantification of emission details

2. Impacts quantification in terms of air, water; visual; ozone creation; global warming and waste

3. Comparison of effects

4. Resolution of cross media effects

5. Comparison of BREF/BAT Conclusions Recommendations

5.1 Emission Details

5.1.1 Emissions Inventory

25% w/w ammonium hydroxide solution is used in the process for pH control. The ammonia solution will be pumped from 950L stainless-steel IBCs in the bunded area outside Building 18 to a 300L (working volume) head tank (TK-582) within the building. The head-tank is pressurised to 2 barg in order to allow pressure transfer to the fermenters. The head tank TK-582 will vent to the ammonia abatement system when the pressure exceeds 2 barg, or at the end of the batch.

During the transfer of the ammonium hydroxide solution to the day tank (Case A) the characteristics of the gas stream flow to the abatement system are as follows:

- Volumetric flowrate: 0.96 Nm3/hr (flowrate advised by fermenter package vendor)

- Ammonia flowrate in gas stream: 136 g/hr (instantaneous); 28 g/hr (60 min mean)

- Duration of ammonia/air gas flowrate: 12.5 min

- Frequency of occurrence of ammonia/air gas stream: Six times a week

During the 2 barg venting of head tank TK-582 (Case B) the characteristics of the gas stream flow to the abatement system are as follows (obtained from PM calculation document number IE0311878-41-CA-0013):

- Volumetric flowrate: 20 Nm3/hr (limited by flow orifice)

- Ammonia flowrate in gas stream: 2567 g/hr (instantaneous); 173 g/hr (60 min mean)

- Duration of ammonia/air gas flowrate: 4 min

- Frequency of occurrence of ammonia/air gas stream: Once a week (or during upset condition)

5.1.2 Release Details

The exhaust release height for the water-based scrubber will be 3.5 metres, which includes a 200mm plinth on which the scrubber will be placed. The release height of the acid based scrubber is similar.

5.1.3 Discharges to Surface Water

There are no discharges to surface water associated with either scrubber option.

5.1.4 Energy Consumption

There are no motors associated with the water based scrubber system. A small circulation pump is required for the acid based scrubber system.

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5.1.5 Raw materials consumed

For the water scrubber unit, water is normally consumed at a rate of 10-20 litres/hr (Case A) and at a rate of 500 litres/hr once a week for 5 minutes (Case B).

For the acid scrubber system, assuming a 500 litre sump it is estimated that approximately 2000 kg of 10% w/w sulphuric acid solution would be used on an annual basis.

5.1.6 Waste streams emitted

Emissions to Air: The abatement efficiency possible for both the water and acid scrubbers are the same as both are gas-phase limited processes with the rate of absorption governed by conditions in the gas phase. The abatement efficiency will be designed to achieve the following regarding the exhaust point to air (for both Cases A and B outlined in Section 5.1.1):

- Ammonia concentration: 10 mg/Nm3

- Abatement efficiency: > 99.9%

- Ammonia mass flowrate: < 0.001 kg/hr

Liquid waste Emissions: For the water scrubber, the liquid waste stream will be the same quantity as the water consumed plus the ammonia inlet flowrate, resulting in an approximate ammonia concentration of 14 mg/m3.

For the acid-based scrubber ammonium sulphate salt will be generated as the sulphuric acid is converted by ammonia absorbed from the gas; this dilute salt/sulphuric acid solution would require transportation off-site for disposal (quantity would approximately equal the raw material quantity of 10% sulphuric acid plus the ammonia inlet flowrate to the scrubber).

5.2 Impacts Quantification

5.2.1 Air Impacts

Both scrubber options will result in the same waste gas emissions to air. The BAT Reference (BREF) for the Manufacture of Organic Fine Chemicals8, list the BAT associated mass flow emission levels for ammonia as 0.001 – 0.1 kg/hr. As the mass flowrate from the scrubber will be below the lower threshold value the environmental impacts of the emissions to air are insignificant. This is further confirmed by using a dispersion factor specified by the UK DEFRA2 to estimate the worst case ground level concentration based upon the post-abatement ammonia mass flowrate. Comparison of the worst case ground level concentrations against the ammonia environmental assessment levels in Table 2 along with the odour threshold criteria of Table 4 indicates an insignificant environmental impact.

5.2.2 Water Impacts

The scrubber will be located in a bunded area therefore no releases to surface water are anticipated.

For the water scrubber, water is consumed at the rate indicated in Section 5.1.5. Refer to the resolution of cross-media effects regarding the minimisation of water consumption.

No water impacts are associated with the acid-based scrubber.

5.2.3 Noise Impacts

There are no motors associated with the water scrubber; hence no noise impacts are anticipated. The acid scrubber will require a small pump motor and may therefore generate slightly more noise but negative noise impacts are not predicted.

8 BREF Manufacture of Organic Fine Chemicals, Aug. 2006, European Commission. Available at:

http://eippcb.jrc.ec.europa.eu/reference/ofc.html

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5.2.4 Visual Impacts

There is no difference in the visual impact between both scrubber options. Given the relative heights of the surrounding buildings and structures the visual impact is not significant.

5.2.5 Photochemical Ozone Creation Impacts

No photochemical ozone creation impacts are associated with ammonia.

5.2.6 Global Warming Potential Impacts

No global warming impacts are associated with ammonia.

5.2.7 Waste Impact

MSD Brinny has confirmed that the site’s waste water treatment plant has sufficient capacity to treat the waste liquid stream from the water-based scrubber.

The waste liquid stream from the acid-based scrubber will require off-site disposal of the waste sulphuric acid.

5.3 Comparison of Environmental Impacts between Options

There is no difference in terms of the air and visual impact between the two scrubber options. There is higher raw material consumption as regards the water-based scrubber however the waste liquid stream is more easily handled and does not require off-site disposal. In addition, the raw material associated with the water-based scrubber is obviously less hazardous than that required for the acid scrubber system.

5.4 Resolution of Cross Media Effects

The cross media effects associated with both scrubber systems is the generation of waste liquid effluent. Water consumption associated with the water-based scrubber is minimised, as far as practicable, by the installation of a high and low flowrate actuated valves on the water supply line to the scrubber. Only during the higher venting flowrate to the scrubber (Case B), is the higher water flowrate line activated by the automation system.

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IE0311878-22-RP-0002, Issue A13/12/2017

IE0311878-22-RP-0002_A_01.DOCX Formal Issue

5.5 BREF Documents/ ‘BAT Conclusions’ Assessment

The following documents were reviewed for this assessment:

BAT Guidance Notes on Best Available Techniques for Pharmaceutical and other Speciality Organic Chemicals, 2008

BAT Reference (BREF) document for the Manufacture of Organic Fine Chemicals, Aug 2006

‘BAT Conclusions’ for common waste water and waste gas treatment/management systems in the chemical sector, 2016

BREF for Common Waste Water and Waste Gas Treatment / Management Systems in the Chemical Sector, 2016

The scope of the assessment is limited to the ammonia abatement treatment technologies.

NOTE: Only ‘BAT Conclusions’ and BREF recommendations that allow differentiation between the different technologies or that are required to demonstration that the technology is BAT are only included in this review.

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MSD Brinny Project Lion

IE0311878-22-RP-0002, Issue A 13/12/2017


Table 6 BAT Conclusions/BREF Document Assessment

Item

No

BAT/BREF Ref No

BAT Conclusion/ BREF Requirement Option A – Water Scrubbing Ammonia Abatement

Option B – Acid Scrubbing Ammonia Abatement

Comments on Differences

BAT Guidance Notes on Best Available Techniques for Pharmaceutical and other Speciality Organic Chemicals, 2008

BAT Reference (BREF) document for the Manufacture of Organic Fine Chemicals, Aug 2006 (bracketed reference No.)

1 5.3.6 Minimisation of Energy There are no motors associated A small circulation pump is Slightly more energy

(5.1.2.6) Consumption

BAT is to assess and implement options to minimise energy consumption, e.g. apply pinch

with the scrubber. Minimal power draw associated with instrumentation

required, in addition to power requirements for instrumentation

consumption associated with the acid scrubber due to the requirement for a recirculation pump

technology to optimise energy balanceon production site (see BREF Section4.2.10).

2 5.4.3

(5.2.1.1.4 para 3)

Treatment of Gaseous Residues

BAT is to individually monitor substances with ecotoxicological potential is such substances are released (see BREF Sections 4.3.1.8 & 5.2.1.1.4).

Ammonia monitoring will be provided on the exhaust line to atmosphere from the scrubber

Same comments as per the water scrubber

N/A

3 5.4.3

(5.2.1.1.4 para 1)

BAT is to monitor emission profiles, which reflect the operational mode of the production process (batch, semi- continuous, continuous) for gaseous emissions instead of monitoring levels for short sampling periods (see BREF Section 4.3.1.8 & 5.2.1.1.4).

Monitoring of ammonia to be provided


N/A

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Item

No

BAT/BREF Ref No




4 5.4.3.4.

(5.2.3.4)

Removal of NH from Exhaust Gases 3

BAT is to minimise the NH3 emissions and where necessary, to apply scrubbing with H2O or acidic scrubbing media (see BREF Section 4.3.5.20)

BAT is to achieve NH3 emission levels of 0.1 to 10 mg/Nm3 or 0.001 – 0.1 kg/hr

Water based scrubbing system which will achieve a post- abatement emission mass flowrate < 0.001 kg/hr (instantaneous flowrate)

Acid based scrubbing system which will achieve a post-abatement emission mass flowrate < 0.001 kg/hr (instantaneous flowrate)

Difference in the scrubbing raw material used with the acid based scrubbing system using a more

5 5.4.5.1

(5.2.4.1.3)

BAT is to segregate and collect separately spent acids (e.g. from sulphonations or nitrations) for on-site or off-site recovery unless it is not technically possible (see BREF Sections 4.2.24, 4.3.2.6 & 4.3.2.8).

N/A – waste acids not generated Collection and disposal off- site of waste sulphuric acid is required

Off-site disposal of waste sulphuric acid solution required for acid scrubbing system

6 6.1 Table 6.1 BAT Associated Emission Levels for Emissions to Air

Ammonia: Emission Level (mg/m3) = 30 mg/m3; Mass flow threshold = 150 g/hr

Where the Mass Flow in the raw gas exceeds the mass flow threshold given in the Table, abatement will be required to reduce the emission to below the appropriate emission level or mass flow threshold

NOTE: These BAT emission levels are superseded when technology options currently regarded as BAT can achieve greater abatement efficiencies

Design ammonia post abatement concentration is 10mg/Nm3 with an ammonia mass flowrate < 0.001 kg/hr


N/A

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Item

No

BAT/BREF Ref No




‘BAT Conclusions’ for common waste water and waste gas treatment/management systems in the chemical sector, 2016

7 BAT 1 Outlines various requirements for the site’s Environmental Management System

No difference between the different options as regards this requirement


N/A

8 BAT 2 (i) Relates to chemical production processes and is therefore not applicable

N/A N/A N/A

9 BAT 2 (ii) “Information, as comprehensive as is reasonably possible, about the characteristics of the waste water streams, such as:

a) Average values and variability of flow, pH, temperature and conductivity;

b) Average concentration and load values of relevant pollutants/parameters and their variability (e.g. COD/TOC, nitrogen species, phosphorus, metals, salts, specific organic compounds);

c) Data on bioeliminability (e.g. BOD, BOD/COD ratio, Zahn-

The Waste liquid stream will be directed to the WWTP for treatment. For the majority of the time, the waste liquid stream will consist of water at a rate of 10-20 litres/hr. During the low flow venting condition to the scrubber, the waste stream will also contain the ammonia load present in the exhaust gas of approximately 28 g/hr (60 min mean), giving an approximate ammonia concentration of 14 mg/m3. Once a week (or during a process upset condition) a higher ammonia/air exhaust will be directed to the scrubber for approximately 5 minutes. During this high flow

N/A – waste liquid not sent to the WWTP

For the water-based scrubber, liquid waste will be directed to the WWTP for treatment

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Item

No

BAT/BREF Ref No




Wellens test, biological inhibition potential (e.g. nitrification)”

venting scenario water at a rate of approximately 500 litres/hr will be directed to the WWTP plus the removed ammonia load in the exhaust gas stream of approximately 173 g/hr.

(NOTE: values referenced here are obtained from PM calculation document number IE0311878-41- CA-0013)

10 BAT 2 (iii) “Information, as comprehensive as is reasonably possible, about the characteristics of the waste gas streams, such as:

a) Average values and variability of flow and temperature;

b) Average concentration and load values of relevant pollutants/parameters and their variability (e.g. VOC, CO, SOx, chlorine, hydrogen chloride)

c) Flammability, lower and higher explosive limits, reactivity;

d) Presence of other substances that may affect the waste gas treatment system or plant safety (e.g. oxygen, nitrogen, water vapour, dust)”

An ammonia detector on the exhaust stream will monitor the concentration of ammonia present post-abatement.


N/A

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Item

No

BAT/BREF Ref No




11 BAT 3 “For relevant emissions to water as identified by the inventory of waste water streams (see BAT 2), BAT is to monitor key process parameters (including continuous monitoring of waste water flow, pH, and temperature) at key locations (e.g. influent to pretreatment and influent fo final treatment)”

N/A – relates to WWTP N/A N/A

12 BAT 4 “BAT is to monitor emissions to water in accordance with EN standards with at least the minimum frequency given below. If EN standards are not available, BAT is to use ISO, national or other international standards that ensure the provision of data of an equivalent scientific quality.”

Refer to BAT 4 Table

N/A – relates to WWTP monitoring N/A N/A

13 BAT 5 Outlines monitoring requirements for diffuse VOC emissions

N/A – ammonia is not a VOC N/A N/A

14 BAT 6 “BAT is to periodically monitor odour emissions from relevant sources in accordance with EN standards.

Description

N/A (No odour impacts are predicted due to the high abatement efficiency of the scrubber)


N/A

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Item

No

BAT/BREF Ref No




Emissions can be monitored by dynamic olfactometry according to EN 13725. Emissions monitoring may be complemented by measurement/estimation of odour exposure or estimation of odour impact.

Applicability

The applicability is restricted to cases where odour nuisance can be expected or has been substantiated”

15 BAT 7 “In order to reduce the usage of water and the generation of waste water, BAT is to reduce the volume and/or pollutant load of waste water streams, to enhance the reuse of waste water within the production process and to recover and reuse raw materials”

Water consumption associated with the water-based scrubber is minimised, as far as practicable, by the installation of a high and low flowrate actuated valves on the water supply line to the scrubber. Only during the higher venting flowrate to the scrubber is the higher water flowrate line activated by the automation system.

N/A Water usage and waste water generation is associated with the water- based scrubber system.

16 BAT 8 “In order to prevent the contamination of uncontaminated water and to reduce emissions to water, BAT is to segregate uncontaminated waste water streams from waste water streams that require treatment.”

Not applicable as once the water comes into contact with the scrubber packing material it may contain trace quantities of ammonia.

N/A N/A

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Item

No

BAT/BREF Ref No




17 BAT 9 “In order to prevent uncontrolled emissions to water, BAT is to provide an appropriate buffer storage capacity for waste water incurred during other than normal operating conditions based on a risk assessment (taking into account e.g. the nature of the pollutant, the effects on further treatment, and the receiving environment), and to take appropriate further measures (e.g. control, treat, reuse)”

N/A – relates to WWTP design N/A N/A

18 BAT 10 “In order to reduce emissions to water, BAT is to use an integrated waste water management and treatment strategy that includes an appropriate combination of the techniques in the priority order given below.”

Refer to BAT 10 table of techniques

The response to BAT 7 outlines how the waste liquid stream to the WWTP is minimised. Process integration methods, such as the use of a balancing line to reduce the ammonia/air exhausts requiring treatment are not practical in this case due to the requirement to treat a pressurised flowrate (2barg).

N/A N/A

19 BAT 11 “In order to reduce emissions to water, BAT is to pretreat waste water that contains pollutants that cannot be dealt with adequately during final waste water treatment by using appropriate techniques”

Not applicable as the waste liquid stream from the scrubber can be treated by the site’s WWTP

N/A N/A

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Item

No

BAT/BREF Ref No




20 BAT 12 Relates to final waste water treatment techniques

N/A – relates to WWTP design N/A N/A

21 BAT 13 In order to prevent or, where this is not practicable, to reduce the quantity of waste being sent for disposal, BAT is to set up and implement a waste management plan as part of the environmental management system (see BAT 1) that, in order of priority, ensures that waste is prevented, prepared for reuse, recycled or otherwise recovered.”



N/A

22 BAT 14 Relates to waste water sludge N/A N/A N/A

23 BAT 15 “In order to facilitate the recovery of compounds and the reduction of emissions to air, BAT is to enclose the emission sources and to treat the emissions where possible.”

Abatement system being provided to reduce emissions of ammonia to air

Abatement system being provided to reduce emissions of ammonia to air

N/A

24 BAT 16 “In order to reduce emissions to air, BAT is to use an integrated waste gas management and treatment strategy that includes process-integrated and waste gas treatment techniques.”

Process integration methods, such as the use of a balancing line to reduce the ammonia/air exhausts requiring treatment are not practical in this case due to the requirement to treat a pressurised flowrate (2barg).


N/A

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Item

No

BAT/BREF Ref No




25 BAT 17 & 18

Relates to emissions to air from flares N/A N/A N/A

26 BAT 19 Relates to techniques for the prevention or reduction of diffuse VOC emissions.

N/A N/A N/A

27 BAT 20 Relates to the elements that an odour management plan, as part of an EMS, needs to contain

Restricted to cases where odour nuisance can be expected or has been substantiated.

N/A (No odour impacts are predicted due to the high abatement efficiency of the scrubber)


N/A

28 BAT 21 Relates to the prevention or reduction of odour emissions from waste water collection and treatment and from sludge treatment

N/A N/A N/A

29 BAT 22 “In order to prevent or, where that is not practicable, to reduce noise emissions, BAT is to set up and implement a noise management plan, as part of the environmental management system (see BAT 1), that includes all of the following elements:

(i) A protocol containing appropriate actions and timelines;

(ii) A protocol for conduction noise monitoring;

No pumps associated with the scrubber therefore low noise levels are anticipated, therefore inclusion in a noise management plan is not necessary

A small pump motor will generate relatively low noise levels, therefore inclusion in a noise management plan is not necessary

Slightly more noise emissions associated with the acid-based scrubber system

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Item

No

BAT/BREF Ref No




(iii) A protocol for response to identified noise incidents;

(iv) A noise prevention and reduction programme designed to identify the source(s), to measure/estimate noise exposure, to characterise the contributions of the sources and to implement prevention and/or reduction measures.

Applicability

The applicability is restricted to cases where noise nuisance can be expected or has been substantiated”

30 BAT 23 Relates to techniques for the prevention or reduction of noise emissions.

Refer to BAT 23 Table for the relevant techniques

N/A N/A N/A

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IE0311878-22-RP-0002, Issue A 13/12/2017

6 Conclusions

Given the analysis in the previous sections, both the water and acid scrubber units can be regarded as representing BAT for the abatement of ammonia arising from the waste gas stream described in this report. The cross media effects associated with both technologies involve the generation of liquid wastes. In the case of the water scrubber the liquid waste, which can be treated using the site’s WWTP, is kept to a minimum through the use of automated valves and the process control system so that the higher water flowrate is normally only used once a week for a limited duration. In the case of the acid scrubber, the waste liquid acid generated would require off-site disposal. As discussed previously in Section 3.1, one of the considerations in determining BAT is the use of less hazardous substances. Given the requirement to use hazardous sulphuric acid solution with the acid scrubber and the related process safety issues in its use and subsequent disposal the water scrubber is regarded as the better technology option.

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