ippc application form · closure of cs1 and cs2, tank farm 1600 (tf1600), part of tf600 and other...

IPPC Application Form

Klinge Pharma Licence Application Form.doc 0 of 118

SECTION A NON-TECHNICAL SUMMARY

Non-Technical Summary of IPC Licence Application A non-technical summary of the application is to be included here. The summary should identify all environmental impacts of significance associated with the carrying on of the activity/activities, and describe mitigation measures proposed or existing to address these impacts. This description should also indicate the normal operating hours and days per week of the activity. The following information must be included in the non-technical summary: A description of: − the installation and its activities, − the raw and auxiliary materials, other substances and the energy used in or

generated by the installation, − the sources of emissions from the installation, − the conditions of the site of the installation, − the nature and quantities of foreseeable emissions from the installation into each

medium as well as identification of significant effects of the emissions on the environment,

− the proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation,

− where necessary, measures for the prevention and recovery of waste generated by the installation,

− further measures planned to comply with the general principles of the basic obligations of the operator i.e.

(a) all the appropriate preventive measures are taken against pollution, in

particular through application of the best available techniques; (b) no significant pollution is caused; (c) waste production is avoided in accordance with Council Directive

75/442/EEC of 15 July 1975 on waste; where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;

(d) energy is used efficiently; (e) the necessary measures are taken to prevent accidents and limit their

consequences; (f) the necessary measures are taken upon definitive cessation of activities to

avoid any pollution risk and return the site of operation to a satisfactory state. − measures planned to monitor emissions into the environment. Supporting information should form Attachment N

o A.1

A Non-Technical Summary is presented as Attachment No. A.1

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Attachment A.1 Non Tech Summary November 2006.doc

IPPC Licence Application

Astellas Deutschland GmbH trading as Klinge Pharma & Co.

Killorglin, Co. Kerry

Attachment No. A.1

-Non Technical Summary

November 2006 Issue No 1 46171701

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Klinge Pharma IPPCL Application Attachment No. A.1


Page 2

CONTENTS

Section Page No

1. INTRODUCTION.............................................................................................................. 3

1.1. History of the Site ............................................................................................................. 4

2. FACILITY OPERATIONS ................................................................................................ 5

2.1. Products ........................................................................................................................... 5 2.2. Raw Materials................................................................................................................... 6 2.3. Auxiliary Materials ............................................................................................................ 6 2.4. Class 12.2.2 Activities ...................................................................................................... 7

3. EMISSIONS TO ATMOSPHERE..................................................................................... 7

3.1. Point Source Emissions ................................................................................................... 7 3.2. Fugitive Emissions ........................................................................................................... 9 3.3. Control & Abatement Technology .................................................................................... 9 3.4. Assessment of Impact of Atmospheric Emissions ......................................................... 10

4. EMISSIONS TO SURFACE WATER............................................................................. 10

4.1. Non Process Water ........................................................................................................ 10 4.2. Process Water................................................................................................................ 10 4.3. Assessment of Impact of Emissions to Surface Waters ................................................ 11

5. EMISSIONS TO GROUND ............................................................................................ 12

6. SITE CONDITION .......................................................................................................... 12

6.1. Environmental Setting .................................................................................................... 12 6.2. Current Groundwater Monitoring.................................................................................... 12

7. NOISE EMISSIONS ....................................................................................................... 14

8. WASTE MANAGEMENT ............................................................................................... 15

9. SAMPLING AND MONITORING................................................................................... 15

10. ENERGY EFFICIENCY.................................................................................................. 15

11. CONTAINMENT OF ACCIDENTAL SPILLAGES......................................................... 16

12. EMERGENCY RESPONSE ........................................................................................... 17

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Page 3

CONTENTS

Section Page No

13. APPLICATION OF BEST AVAILABLE TECHNIQUES AT KLINGE PHARMA .......... 18

14. DECOMMISSIONING .................................................................................................... 18

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Attachment A.1 Non Tech Summary November 2006.doc Page 3

1. INTRODUCTION

This Integrated Pollution Prevention & Control (IPPC) licence application is for Astellas

Deutschland GmbH. The site in Killorglin is a branch of Astellas Deutschland GmbH

However, the company is commonly known as and trades as Klinge Pharma & Co.

Therefore, to avoid confusion the applicant is referred to as Klinge Pharma throughout

this application. The IPPC licence for which this application is made replaces an existing

licence, Licence Register No. P0018-01 for Klinge Pharma & Co.

The site is a 9.29 hectares industrial site located on the N70 approximately 1km east of

Killorglin town centre in Co. Kerry. The site operates on a 24-hour, 3-cycle shift, 5 days

per week basis, with occasional weekend work determined by production demands.

Surrounding land use in the vicinity of the site is a combination of industrial, amenity,

residential and agricultural with neighbouring land use as follows:

North: River Laune and Agricultural Land

West: Industrial (Astellas Ireland Company Ltd - AICL) & Killorglin Town

South: Agricultural Land and residential housing along the N70

East: Agricultural Land and residential housing

A Site Location Map is presented in Attachment No B.2 (Drawing Reference 106101-

01) of Attachment B and a Site Layout Plan is presented in Appendix No. D-2 (Drawing

Reference 106101-02) of Attachment D.

Production facilities on the site have not changed since the original application to the EPA

for an IPC licence in 1995. However API production is due to cease at Klinge Pharma at

the end of 2006 with decommissioning due to commence in 2007. This will result in the

closure of CS1 and CS2, Tank Farm 1600 (TF1600), part of TF600 and other significant

areas within the site. It is the first decommissioning project of this magnitude to be

undertaken by Klinge Pharma and as a result, a dedicated project in the Environmental

Management Programme (EMP) is in place to ensure that all environmental aspects of

the decommissioning are considered. Appendix D-1 of Attachment D contains a

proposal from an engineering firm to decommission all API facilities on site which Klinge

Pharma have accepted. Following API decommissioning, the two remaining production

groupings and the subject of this licence application will be:

(a) Pellet Production and

(b) Pellet Ingredients

The key site facilities are:

• QC Labs, Administration and Canteen

• Warehouses

• Production Plants

• Drum Store

• Engineering Workshop and Stores

• Environmental Health and Safety Offices and Laboratory

• Tank Farms

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• Wastewater treatment plant

• Utilities buildings.

The purpose of this IPPC licence application is to:

• Replace the existing IPC licence with a new licence that should reflect the

requirements of the IPPC Directive and related Irish legislation; and

• Reflect changes on the site that have arisen since the date of granting of the

current IPC licence.

The Class of Activity, as defined in Schedule 1 to the Protection of the Environment Act,

2004, applicable to Klinge Pharma for this application is:

• Class 12.2.2: The manufacture or use of coating materials in processes with a

capacity to make or use at least 10 tonnes per year of organic solvents.

Klinge Pharma was originally licensed under Class 5.6 in 1995. However, with the

closure of the API facility at the end of 2006 Class 5.6 or its current equivalent 5.16 is not

considered relevant.

1.1. History of the Site

Prior to the construction of the Klinge Pharma Facility in 1972, an old carpet factory was

located on site along with a number of trees, grassland, bramble, gorse and other types

of wild vegetation. Parts of the site would have been utilised for agricultural purposes.

The site was bounded to the north by the river Laune and agricultural land, to the west by

a mix of one off housing and undeveloped agricultural land, to the south and east by

agricultural land and residential housing.

Construction works on site began in the early 1970’s and the plant began production in

1972 with the manufacture of Kavain. The following is a summary of the significant

changes that took place to the physical layout of the site since then:

Year Developments

1972 Foundation of Klinge Pharma in Killorglin, primarily to manufacture bulk active ingredients and pharmaceutical formulations to supply parent Company and Licencees.

1974 Production facilities for extraction of Horsechestnuts and isolation of Escin were constructed.

1975 Extension of Warehousing facilities and utilities. Commencement of production of sustained release pellets.

1976 Production start-up of Horsechestnut Pellets.

1980 Multipurpose Chemical Synthesis facilities completed.

1984 Extension of pellet production unit for manufacture of sustained release pellets: Theophylline, Pentoxifylline.

Upgrade of Chemical Synthesis plants for new chemical products Febuprol, Tamoxifen Citrate, Dipivefrine.

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Year Developments

1986 Modern Engineering Workshop constructed.

1988 Establishment of Klinge Pharma Sales and Marketing for Irish market.

Purchase of additional 200,000m² of land at plant in Killorglin

1989 Decision by Fujisawa to locate Prograf facility in Killorglin.

1990 Opening of new QC laboratory and new Canteen.

1992 Construction of new Pellet Plant, Modernisation of Chemical Production plant. Extension of Utility and Environmental services.

1992-1997

Pellet production completely transferred to new pellet facility.

Integrated Pollution Control licence issued.

1998-1999

Begin Production Transfer of chemical products from Fujisawa Japan, Zotepine successfully transferred.

Upgrade of Extraction Plant, building 3

2000 Construction of New Chemical Synthesis Pilot Plant CS3.

2003 Beginning of manufacture of pre-clinical and clinical samples for Fujisawa Japan

In 1988, part of the existing site was used by Fujisawa, Japan (Klinge Pharma Parent

Company – now known as Astellas Pharma Inc.) to construct another manufacturing

facility - Astellas Ireland Company Ltd. (AICL). This facility was constructed in the eastern

area of the site. Although both companies are currently owned by Astellas Pharma, both

facilities act as separate companies with separate management structures and separate

workforce. Certain services are shared by both, these include wastewater treatment,

emergency services and emergency generators. It should be noted that all of these

services are owned and maintained by Klinge Pharma.

2. FACILITY OPERATIONS

2.1. Products

The products produced on site in Pellet Production and Pellet Ingredients are:

• Horsechestnut Extract

• Diclofenac Sodium Pellets

• Theophylline Pellets

• Horsechestnut Extract Pellets

• Pentoxifyilline Pellets

• Nilvadipine Pellets

• Omeprazole Pellets

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2.2. Raw Materials

The raw materials needed to produce these products are:

Acetone Aerosil 200 Antifoam

Avicel PH101 Avicel PH105 Croscarmellose Sodium

Dextrine Deionised Water Diclofenac Sodium

Ethanol Ethyl Cellulose 20CPS Eudragit L100-55

Eudragit L30 D55 Eudragit RL100 Eudragit RS100

Horsechestnut Extract Horsechestnuts Hydroxypropylcellulose (Klucel

EF)

Isopropyl alcohol Kollidon 25 Kollidon VA64

Magnesium Carbonate,

heavy

Maize Starch Microtalc

Nilvadipine Omeprazole Palatinol C (Dibutylphthalate)

Pentoxifyilline Polyethyleneglycol 6000 Propyleneglycol

Saccharose Sodium hydroxide, pearl Sodium Laurylsulphate

(Texapon K 12)

Sugar Spheres Talcum Theophylline

Titanium Dioxide

2.3. Auxiliary Materials

The auxiliary materials used on site comprise:

Cortrol IS3000E Dianodic DN2471 Optisperse PO5090

Inhibitor AZ8104 Spectrus BD1500 Spectrus OX1201

Sodium Hypochlorite,

14-16%

Bactericidal Hydroclean Traywash detergent

Chematic 901 Ethylene Glycol Sodium Hydroxide, 25%

Hydrochloric Acid, 36% Granular Salt Ferric Sulphate

Sulphuric Acid 1.4 Hydrated Lime Zetag 7875

Foamtech Nutrient (Purisol) Light Fuel Oil (200sec)

Gas Oil (35sec) Lubricating oils Engine Oils

Atomix_IX 950 Liquid Nitrogen Carbon

Cosa Foam 40 Cosa DES Cosa Pur 85

Cosa CIP 92 Cosa CIP 72 Nitric Acid 20-70%

Compressed Gases: Acetylene, Argon, Hydrogen, Helium. Air, Oxygen, Nitrogen

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2.4. Class 12.2.2 Activities

Klinge Pharma is a pharmaceutical facility engaged in the manufacture of a wide range of

products for the treatment of diseases. The main activities are conducted in three

buildings on site Pelletising Plant 1 (Building 7) and Pelletising Plant 2 (Building 19) and

Extraction/Spraydrying (Building 3). Drawing Reference 106101-02 in Appendix D-2 of

Attachment No. D outlines the locations of all buildings on site.

Building 19 – Pelletising Plant 2: is the new pelletising plant used for the production of

pharmaceutical pellets from powder, which are sold in bulk form. All products

manufactured in the plant are multi-dose form non-sterile products suitable for oral

administration. The manufacturing process briefly consists of dispensing of solid raw

materials; granulation using solvent; drying to remove the solvent; sieving; milling and

coating of selected pellets with a solvent or aqueous based lacquer medium. All products

manufactured in the plant are produced in a similar manner.

Building 19 also has its own warehouse which is located in the west end of the building.

The main entrance, staircase, offices and staff welfare and changing facilities are located

at the eastern end of the building together with MCC Switch Room, Instrument Rack

Room and Extract Rooms. Chiller, HVAC and Solvent Recovery Plant rooms are located

on the first floor, mainly over the production areas.

Building 3 – Extraction/Spraydrying is the main activity of the Pellet Ingredients

department. A spray-dried extract of the horsechestnut seed is produced in the plant. The

manufacturing process consists of milling, solid-liquid extraction using aqueous ethanol,

evaporation and spraydrying. Some of the spray-dried extract is used in Pellet production

while more is sold direct in powder form to customers.

Building 7 - Pelletising Plant 1, located in the northern part of the site is the older

pelletising plant used for pellet production. This process is essentially the same as in

building 19, but on a much smaller scale. Building 7 is also used by Pellet Ingredients

department. Milling of raw material for subsequent use in Pellet Production is carried out

here. Other activities include belt separation, blending and packing of finished pellets.

There is a QC laboratory upstairs in building 7 which is used to test pellets.

Monitoring and control of the manufacturing processes is achieved though the use of

instrumentation which measure and control, for example, pressures, temperatures, levels,

flows, agitator speeds and various analytical properties, as required by the individual

processes. Process instrument and motive equipment data is fed to centralised control

systems that are monitored 24 hours per day.

3. EMISSIONS TO ATMOSPHERE

3.1. Point Source Emissions

A summary list of main emissions points to atmosphere is provided in Table A.1.

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Table A.1 – Details of Main Emission Points.

Emission Ref.

No. Area

Description

(priority pollutant) Grid Reference

A1-1 Building 2, Boiler

House

Exhaust Fumes from Boiler B-501 E078637

N097104


House


N097101


House


N097112

A2-1 Building 19, Pellet

Plant

Exhaust from central vacuum system

(dust)

E078596

N097019

A2-2 Building 19, Pellet

Plant

Exhaust from point extract system

(dust)

E078598

N097018

A2-3 Building 3, Chemical

Synthesis 1

Currently exhausts via A2-4. Will be

decommissioned when API ceases

production at the end of 2006.

However, the point is to be retained in

case of future use of the building.

E078611

N097075

A2-4 Building 8, Chemical

Synthesis 2

Process Vent – this point will be

decommissioned when API ceases

production at the end of 2006.

However, the point is to be retained in

case of future use of the building.

E078587

N097062

A2-5 Building 7 Currently accepting minor emissions

form a small vacuum system. Not a

main emission at present but is being

declared as such to allow for potential

future upgrade of the process.

E078675

N097146

A2-6 Building 7 No exhaust at present however may be

used in future

E078659

N097156

There are many minor emissions to atmosphere, broadly categorised as follows:

� Generator Exhausts;

� Process Vents;

� Laboratory emissions.

The minor emissions are considered to have emissions to atmosphere of pollutants

significantly less than those of the main emissions and are not environmentally

significant.

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3.2. Fugitive Emissions

Fugitive emissions are largely generated in the following operations on the site:

� Bulk storage tank filling;

� Building ventilation (not otherwise classified as a minor emission).

Klinge Pharma annually completes a Pollution Emission Register (PER), which includes

the estimation of fugitive emissions of certain priority substances. The PER is contained

in the Annual Environmental Report.

Council Directive 1999/13/EC on the limitation of emissions of volatile organic

compounds due to the use of organic solvents in certain activities and installations does

not apply to this facility as Klinge Pharma does not finish the product on site in so far as

the product does not leave the site ready for placement on the shelf and solvent

consumption on site is less than 50 tonnes per annum. Therefore, Klinge Pharma is not

a Scheduled Activity under the Council Directive 1999/13/EC as enforced through the

Emissions of Volatile Organic Compounds from Organic Solvents Regulations 2002 (S.I.

No. 543 of 2002).

3.3. Control & Abatement Technology

The following abatement techniques are applied at Klinge Pharma:

Emission Reference Abatement Technique

A2-1 Building 19 Reverse Jet Filter

A2-2 Building 19 Reverse Jet Filter

A2-5 Building 7 Cartridge Filter

A3-22 Building 3 Water Scrubber

HVACs across the site Filter

The above abatement unit operations are on a preventative maintenance programme.

Klinge Pharma emissions to air abatement systems are listed BAT technologies for the

activities carried out on the following basis:

1. The technology used is noted as BAT technology in relevant BAT guidance

(European BAT Reference Document for the Organic Fine Chemicals Sector,

August 2006);

2. Klinge Pharma achieves a very high degree of compliance with emission limit

values set out in EPA licences.

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3.4. Assessment of Impact of Atmospheric Emissions

Klinge Pharma plans to carry out an Air Dispersion Modelling Assessment of Boiler and

Generator Emissions in the near future, the results of which will be used to assess the

impact of atmospheric emissions.

4. EMISSIONS TO SURFACE WATER

There are two types of surface water emissions from the site: Non- process water (i.e.

storm water drainage) and treated effluent from the Waste Water Treatment Plant

(WWTP). These surface water emissions combine before discharge to the nearby River

Laune.

4.1. Non Process Water

Uncontaminated storm water is discharged from the Klinge Pharma site and the AICL site

to the nearby River Laune from one surface discharge point, IPC Licence reference

‘Surface Water Outfall’. The new IPPC Licence reference for this point will be SW2.

The emissions to surface water are monitored according to Schedule 5 (i) of the IPC

licence. Prior to discharge to the river, the storm water is continuously analysed with a

T.O.C monitor. It can be diverted in the event of a contamination incident to the firewater

retention lagoon, from where it can be assessed and treated in the WWTP if necessary.

4.2. Process Water

Low strength aqueous process effluent, which can be biologically treated, is generated on

site from tank wash down, equipment cleaning, production wastes and domestic sewage.

Full details of emissions from each process are contained in Section D, Infrastructure

and Operation, of the main IPPCL application. The main pollutants in the process

effluent are:

• Trace organic solvents

• Dissolved and suspended solids derived from production

• Inorganic acids and bases.

There are two wastewater streams that discharge to the WWTP. The main process (or

‘Industrial’) effluent line is a combination of three process effluent streams as follows:

• Process effluent from the Klinge Pharma pellet production and pellet ingredients

and site domestic effluent;

• Process effluent from the Klinge Pharma API manufacturing process. This will

cease once the API facility ceases production at the end of 2006;

• Process and domestic effluent from the neighbouring AICL facility.

The second main line is what is called “E line” effluent from the neighboring AICL facility.

This effluent has a dedicated drainage system that first drains to a batch pH adjustment

facility in order to destroy all traces of active ingredients in this effluent. The pH

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adjustment facility is located adjacent to the main WWTP and consists of two small

vessels working on a ‘fill and draw’ basis. Each batch of E line effluent is held for one

hour to ensure completed treatment. The treated effluent from the pH adjustment facility

then discharges to the balancing tanks of the main WWTP where it combines with the

aforementioned industrial and domestic effluent.

Going forward, Klinge Pharma will maintain control over the WWTP and will work with

AICL to ensure that the quality of the effluent received from AICL will not result in an

adverse impact on the WWTP.

This process effluent is treated in an aerobic biological treatment plant before being

discharged to the River Laune from one discharge point, IPC Licence reference ‘W1’. The

new IPPC Licence reference for this point will be SW1.

All wastewater is collected in one of two balance tanks for equalisation and conditioning

prior to discharge to the biological treatment system. The tanks operate on a “flip-flop”

basis. While one tank is filling the other is being pumped to the biological treatment

system. The total capacity of each tank is 500m3. A minimum retention time of two days is

available. Conditioning includes mixing, pH adjustment with acid or caustic/lime, nutrient

addition if required, foam control as required and seeding for bacteria acclimatisation.

The conditioned effluent is pumped at a controlled rate to the activated sludge section.

The activated sludge section consists of four aeration tanks and two clarifiers. The

capacity of each aeration tank is 365 m3, and each clarifier is 60 m

3. Forward feed from

the conditioned effluent can be treated in an inter-stage and a final stage if the plant is

operated in series. Alternatively the plant can be operated in parallel.

Ferric sulphate is dosed into the outflow from the aeration tanks and this improves sludge

settlement and reduces suspended solids in the final effluent. The plant is licenced for a

maximum throughput of 290 m3/day.

Excess activated sludge is ‘wasted’ to a 100 m3 tank from where it is dewatered through a

belt press. Dewatered sludge produced in the WWTP is composted on-site in a

composting tunnel. It is sent off-site for reuse or disposal by an approved contractor.

The emissions to surface water from the WWTP are monitored according to Schedule 2

(ii) of the IPC licence.

The treatment plant is considered BAT technology, and especially as it is also a central

treatment facility for all process effluents.

4.3. Assessment of Impact of Emissions to Surface Waters

The treated wastewater from the on-site biological wastewater treatment plant has a very

low toxicity (based on testing with species agreed with the Agency). Furthermore, water

results at Cloon Island (approx. 150m downstream of the Klinge outfall) for a variety of

parameters are within available Statutory Requirements based on the Salmonid

Regulations and Phosphorus Regulations. Therefore, the treated effluent discharging

from Klinge Pharma is unlikely to be having any significant impact on receiving waters.

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5. EMISSIONS TO GROUND

There are no intended emissions to ground from the Klinge Pharma facility. The company

is monitoring site groundwater in accordance with IPC licence requirements (refer to

Section 6 for more detail).

6. SITE CONDITION

6.1. Environmental Setting

The topographic elevation of the site is approximately 20 metres above Ordnance Datum.

The topography of the surrounding area slopes down towards the River Laune to the

north west of the plant.

A summary of the geological conditions on site is given in the table below.

Stratum Depth Range (m BGL)

Made Ground: Tarmac 0 – 0.15

Made Ground: Clayey, sandy gravel fill 0.15 – 1.4

Drift Deposits: Mainly sands and gravels 0.15 – 9.75

Drift Deposits: Silts and clays 7.0 – 15.0

Bedrock: Limestone bedrock 7.5 +

Surface water drainage from the site is reported to flow to the West and North towards

the River Laune.

Information from the EPA interactive water quality map indicates that the quality of the

River Laune upstream of the town of Killorglin is unpolluted. However the water quality

changes to slightly polluted around the town of Killorglin. This is upstream of the Klinge

Pharma plant.

6.2. Current Groundwater Monitoring

Klinge Pharma have operated a groundwater monitoring programme at the site since

1996, as required by their IPC licence. Groundwater has been sampled biannually from

six monitoring wells (MW2 to MW7) and from the firewater well (On Site Well 1 or OSW1)

at the Klinge Pharma site (see Drawing Reference. 106101-03 contained in Appendix

E.1.1). MW1 was dry and was not installed as a well.

MW2 to MW7 are located to the northwest of the plant between the main production

areas and the River Laune and were interpreted as being down hydraulic gradient from

the Klinge Pharma Plant. The wells were surveyed to a common datum (Irish Ordnance

Datum) for the first time in 2005 by URS Ireland Ltd (URS) and water levels confirmed

these wells to be downgradient of the plant.

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The most significant issue detected in these early wells was the presence of elevated

monochlorobenzene in MW2 and MW3 which was interpreted as being related either to

issues relating to known leaks (repaired) from the site effluent drains close to MW3 or,

deriving from contaminated soil found below the floor slab of Area 315 in production

building CS1 during reconstruction work in 1990.

In early 2006 URS were requested by Klinge Pharma to carry out additional investigative

works within the production areas and the chemical/fuel storage areas as part of a vendor

due diligence programme due to the planned divestment of the Killorglin site from the

Astellas Pharma group.

Wells MW8 to MW13 were drilled under the supervision of URS close to current or former

chemical and fuel storage areas and current or former underground tanks in mid-

February 2006. These wells unexpectedly indicated groundwater flow to the east or

southeast in the central part of the site and detected elevated chloroform and

trichloroethene concentrations in well MW11, close to the administration building.

The drilling of a planned well in the roadway between production buildings CS1 and CS2

had to be abandoned in February 2006 after several attempts, due to the density of

buried services between the two buildings.

Following a meeting with the EPA in May 2006 to discuss these findings, a further phase

of groundwater investigation was carried out in late July 2006. Well MW14 was drilled in

the roadway next to CS1, and wells MW15 to MW17 were drilled along the eastern and

southern boundaries of the site to investigate potential contaminant migration in these

directions.

The new wells along the eastern and southern boundaries of the site (MW15, MW16 and

MW17) show no evidence of chlorinated solvent contamination or groundwater migration

from the site in an easterly direction.

The seven trial pits dug in the previously uninvestigated green area in the west of the site

show generally gravelly subsoils in this area, with no evidence of undocumented waste

disposal or other signs of contamination encountered.

The additional wells have largely delineated an apparently linear zone of low water levels

running in a NNW-SSE direction beneath the main production areas of the site. This zone

of low water levels coincides with a change in elevation of the bedrock and is inferred to

represent a possible structural feature in the bedrock, (possibly a fracture zone or a

karstic conduit), which is essentially acting as a drain through the middle of the site.

The water table at well MW14 appears anomalous in this area, at 3.06 m aOD. Well

MW14 is screened against low permeability silt just above limestone bedrock and may

represent a localised perched aquifer.

Groundwater levels are higher (3-4 m aOD) to the west of the production areas and

groundwater in this area appears to flow towards the river. The wells along the east of the

site also show higher water levels than beneath the central part of the site.

The detection of elevated chloroform in MW14 indicates that this is the source area for

chlorinated organic solvent contamination (chloroform, trichloroethene), as it is where

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these solvents were formerly stored and used (mid 1970s to mid/late 1980s).

Chlorobenzene was used in CS2 (late 1980’s to 2006).

MW18 to MW22 were installed in September 2006 near the CS1 building and in the

eastern visitors carpark and MW23 was installed to the north of the Pelletising Plant in

October 2006 under the supervision of URS.

The additional wells have proven bedrock elevations along the eastern side of the site

and have clearly shown the limestone bedrock to be karstified, which has important

implications for groundwater flow and contaminant movement within the bedrock. The

karstified limestone is considered the main groundwater flow zone at the Klinge Pharma

site.

The additional wells have delineated a linear zone of low groundwater levels running in a

NE-SW direction beneath the main production areas of the site.

This zone of low water levels coincides with a change in elevation of the bedrock and with

highly fractured, productive water-bearing limestone bedrock. The change in permeability

and water level in this area is inferred to reflect a structural feature in the bedrock (most

likely a karstified fracture zone), which is essentially draining from the middle of the site in

a northeasterly direction.

Downgradient wells in the fracture zone (MW23, OSW2) have detected trace

concentrations of chlorinated solvent contamination (below EPA Guidelines and Irish

Drinking Water Standards) and this suggests that the contamination is diluted and

dispersed within the bedrock fracture zone to trace concentrations within the Klinge

Pharma site.

There is no long-term groundwater monitoring data available for the production area wells

to assess temporal trends in contaminant concentrations at the Klinge Pharma site.

The wells along the eastern and southern boundaries of the site (MW15, MW16, MW17,

MW22) show no evidence of chlorinated solvent contamination or groundwater migration

from the site in an easterly or southerly direction.

7. NOISE EMISSIONS

There are a number of noise sources on the site that Klinge Pharma are required to

monitor annually as per Schedule 4 of the licence. Since the granting of their IPC Licence

Klinge Pharma have increased the number of noise sources that they monitor annually.

Klinge Pharma also monitor noise at a number of sensitive receptors. According to the

latest ANV Technology report for the site ‘The daytime and nighttime noise levels at nearby

houses due to Klinge Pharma were determined to be within the EPA guideline daytime limit

of 55 dB(A), and nighttime guideline limit of 45 dB(A).’

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8. WASTE MANAGEMENT

As part of the on site Environmental Management Programme Klinge Pharma has a number of

waste reduction initiatives. Some major milestones achieved since the original IPC application

include:

• A 63% reduction in packaging material in the form of fibre drums used in the Pellet

Plant in 1996;

• A 50% reduction in use of office paper in 1996;

• Composting of waste water treatment plant sludge allowing diversion of this sludge

waste from landfill;

• A 74% reduction in landfilled wastes from 1999 to 2004;

• A 30% reduction in hazardous waste from 2000 to 2003;

• Recycling initiatives across the site including glass and aluminium recycling in the

canteen and paper recycling in the offices; and

• In 2002 a dedicated building was constructed for sorting of recyclable non hazardous

waste.

9. SAMPLING AND MONITORING

Monitoring of emissions to the environment will be conducted to ensure all

control/treatment systems continue to operate to specification and in compliance with

emission limit values and the requirements of the IPPC licence.

Emissions to air will be monitored from all main emission points which are in use.

Emissions to surface water will be monitored at two emission points, SW1 and SW2.

10. ENERGY EFFICIENCY

A computerised Building Management System (BMS) controls and monitors all energy

usage on site. This system was installed in 1984. The system has been expanded and

updated over the years to encompass the areas such as energy metering, control of

buildings and process services.

The total energy consumed on the entire site in 2005 was 24,242 MW/h’s consisting of

electricity (8,972 MW-h), light fuel oil (12,179 MW-h), Gas Oil (2,787 MW-h) and ABF

(304 MW-h). Water consumption on site (municipal supply) for 2005 was 25,453m3.

As a member of Responsible Care Ireland, Klinge Pharma is required to comply with

various codes of practice including an Energy Management code which requires Klinge

Pharma to have an Energy Policy and Monitor Energy usage to name but a few

requirements.

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To meet their requirements under Responsible Care Ireland Klinge Pharma has

numerous energy objectives in place as outlined below:

• Klinge Pharma has an energy policy which is updated annually;

• An energy officer has been appointed with overall responsibility for reduction in

energy consumption;

• Klinge Pharma has an energy time zone management procedure in place and it

is hoped that the improvements in the management of time zone operation will

have energy consumption savings in the future.

• Klinge Pharma has a monitoring and data capture system in place for all

significant zones to support the long-term goal of driving energy minimisation;

• Klinge Pharma has established monthly and annual reporting on energy

consumption with a view to energy minimisation.

• Klinge Pharma has established an energy training programme which, when

implemented will hopefully increase staff awareness regarding energy

conservation.

• In 2005 Klinge Pharma successfully reduced the non production operation of the

Nitrogen generation plant to the minimum level necessary to support production

thereby reducing the utility non production power load by 24%.

11. CONTAINMENT OF ACCIDENTAL SPILLAGES

Klinge Pharma has in place well developed plans and measures in place to contain and

prevent accidental spillages, with key provisions as follows:

• The storage and containment of all materials at Klinge conform to existing IPC

licence requirements and best practice. Bund capacities incorporate the required

110% of the volume of the largest tank or 25% of the of the total tank volume

within the bund, whichever is the greater. All tank farms are adequately bunded

to prevent any accidental spillage reaching the WWTP. In all cases, discharge

from bunded areas is manually controlled.

• The Drum Store is en-circled with an interception drain which discharges to a

1,000 litre holding tank. This allows small spillages to be impounded, thus

preventing entry to the WWTP.

• The warehouses on site also have interception drains fitted which allow spillages

to be impounded.

• A 3-year rolling bund and drain programme ensures that any deficiencies in

available secondary containment are rectified in a timely manner.

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• Continuous T.O.C monitor on stormwater which can be diverted to the firewater

retention lagoon if higher than usual T.O.C levels are detected and, if necessary,

treated in the WWTP

• The Building Management System (BMS) triggers and records critical alarms, the

basis for emergency ‘call-outs’.

Klinge Pharma also has in place a lined firewater retention pond that has been sized on a

worst case fire scenario and is fitted with a firewater overflow to prevent ground

contamination.

12. EMERGENCY RESPONSE

Under the SEVESO II regulations, EU Directive 96/82/EC Klinge Pharma is not classified

as a SEVESO site.

Klinge Pharma have Standard Operating Procedures (SOPs) and a highly trained Fire

Crew and Emergency Response Team who are on 24 hour call-out in place to deal with

Evacuation and Emergency Procedures. Klinge Pharma has in place a Major Emergency

Plan (Appendix J-1 of Attachment J) covering a wide variety of potential environmental,

safety and health risks, including:

� Fire or Explosion;

� Bulk Chemical/Oil spill;

� Spillage of Water Reactive Chemicals;

� Significant Environmental Damage;

Intrinsic to the Klinge Pharma Emergency Plan are environmental considerations.

Specifically the plan documents detailed actions and procedures in the event of an

environmental release such as a leak or spill.

An Environmental Liabilities Risk Assessment (ELRA) was prepared for the site in 2005.

The ELRA must address liabilities arising from past and present activities and must be

completed by an independent and appropriately qualified consultant.

The following key points from the above ELRA are as follows:

• One of the key environmental risks identified is contaminant leaching into soils

and groundwater – an issue well under control.

• The current environmental management programme on the site has reduced the

risk of the development of new significant environmental liabilities to a low level.

• Insurance cover for the site is considered adequate for risks identified.

• No scenarios have been identified which could result in environmental liabilities

that either exceed the insurance cover or would threaten the financial solvency of

Kilnge Pharma.

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The above ELRA will be revised as required by the EPA.

13. APPLICATION OF BEST AVAILABLE TECHNIQUES AT KLINGE PHARMA

Klinge Pharma incorporates a high standard of Best Available Techniques (BAT) in

operations at the site. Specific BAT of note is as follows:

• The site has implemented Environmental Management Systems certified to ISO

14001 which includes an Environmental Policy and Environmental Management

Programme.

• Klinge Pharma has incorporated sophisticated energy monitoring and targeting

systems, and has carried out energy auditing to identify targets for energy

conservation;

• Klinge Pharma has in place a very rigorous waste management protocol;

• Drainage systems are segregated such that the volumes of wastewater being

sent for on-site wastewater treatment are reduced.

14. DECOMMISSIONING

In the unlikely event of cessation of activities on site, Klinge Pharma will complete a

planned programme of decommissioning incorporating any EPA requirements in this

regard.

A Residuals Management Plan (RMP) was prepared for the facility in 2005. The purpose

of the RMP is to ensure that following termination, or planned cessation for a period

greater than six months, of use or involvement of all or part of the site in the licensed

activity, the licensee shall, to the satisfaction of the Agency, decommission, render safe

or remove for disposal/recovery, any soil, subsoils, buildings, plant or equipment, or any

waste, materials or substances or other matter contained therein or thereon, that may

result in environmental pollution.

The RMP addresses both short/medium-term (Closure Plan) actions and a longer-term

programme (Restoration and Aftercare Management Plan).

The individual stages in the closure plan are:

Stage 1: Production decommissioning, including transfer of residuals to on-site storage;

Stage 2: Removal of excess raw materials, bulk solvent and final product from site;

Stage 3: Removal of production related hazardous/non-hazardous wastes from Site;

Stage 4: Contract cleaning of bulk storage;

Stage 5: Treatment of Bulk Liquid wastes at the on-site WWTP;

Stage 6: Removal of non-process related materials and non-hazardous wastes;

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Stage 7: Decommissioning of site services and on-site WWTP;

Stage 8: Removal of residual hazardous materials; and,

Stage 9: Documentation and Certification of decommissioning and decontamination

The Long Term Programme (LTP) or restoration and aftercare management plan

addresses a number of potential areas of concern on the Klinge Pharma site in relation to

historic operations including raw materials storage, process drains, the former waste

water treatment area and operation/production areas

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ippc application form · closure of cs1 and cs2, tank farm 1600 (tf1600), part of tf600 and other...

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