upgrading a cosmetic industry water system to meet

WQA Aquatech USA 2013 • Indianapolis, Indiana

Upgrading A Cosmetic Industry Water System to Meet USP Purified Water StandardsPresented by: Chris Gallagher,Mar Cor Purification, Inc.

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Standard DisclaimerThe views and theories expressed in the following

presentation represent those solely of the authors, and not any regulatory, or current or previous manufacturers.


Cosmetic Industry/ Contract Manufacturing Manufacturing

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• Some cosmetic industry water standards can be more relaxed than other industries

• By improving and upgrading their critical utilities to comply with more stringent guidelines they can attract more clients

• Opportunities globally to sell products• Process Validation is a key component to assure

system comply’ s with specifications


Typical Guidelines

Water Standards / Guidelines

Microelectronics Power ASTM Pharmaceutical electronics grade

QR 1.2 Type I Type

I I USP27

Conductivity (S/cm)

.0546 <0.10 <0.056 <1.0 <1.3

Resistivity (M-cm) 18.2 >10.0 18.0 >1.0 >0.769 TOC (ppb) <50 100 50 <500 Silica (ppb) <5 <10 <3 <3 none

Bacteria (cfu/ml) <10 none <100 Chloride (ppb) <0.1 <10 1 5 none Sulfate (ppb) 0.1 <10 none Sodium (ppb) <0.5 <10 1 5 none

Endotoxin None None None None Sometimes <0.25eu/ml


Case Study Company X

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• Company was approached to contract manufacture a new product and planned on relocating

• They were audited and had a number of violations.• No P&ID’s • Bacteria (CFU) varied throughout system• Filling of dilution tanks was done with SDI

system that needed to be flushed and sanitized before every fill

• Hose management program not in place


Representative Photo of System

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SDI Make Up System

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User Requirement Specifications (URS)

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• Incorporates quality and quantity of water required• Creation of documentation early in the process

supports the design • Defined by the ISPE as ‘ A description of the

requirements of the facility in terms of product to be manufactured, required throughput and conditions in which the product should be made.’

• In this case the product is purified water.


Company X - Quality of Water

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Line Item Requirement Incoming water Process water

1 Total Organic carbon (ppb) <500 <500

2 Final Filtration (micron) ≤0.2 ≤0.2

3 Microbial (cfu/ml) ≤25 ≤25

5Resistivity @25°C

(units)≥1.0 ≥1.0

6Conductivity @25°C

(ms/cm min)≤1.3 ≤1.3

7 pH 5.7 - 7.0 5.7 – 7.0

8 Flow rate (gpm) ≥1.0 ≥5.0

9 Removal of trace metal ions Yes Yes

10 Sediment Trap/Filtration Yes Yes (post processing)

11 Water Temperature(°C) ambient 51.6

Drawings

(flow chart, electrical, etc.)To be provided To be provided

12 Monitoring and Alarms Yes (tested during IQ/OQ) Yes (tested during IQ/OQ)

13Preventative maintenance schedule and

instructionsTo be provided To be provided

14 Sanitization instructions To be provided To be provided

15 Water System Operation work instructions To be provided To be provided

16Piping

(FDA grade, no dead legs)Required Required


• Determine volume of water required per day.• Determine how many shifts are being run per day.• Determine volume of water required per shift.• Determine maximum peak demand at points of use in

gallons per minute.• Once the above has been acquired, develop the makeup,

storage and delivery volumes required.• Look at future requirements to incorporate this into the initial

design.• Allow a 15 - 20% safety factor.

QUANTITY OF WATER


Functional Requirement Specification(FRS)

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• More detailed documentation on how the system works

• Since the system uses multiple technologies and multiple pieces of equipment this document provides better description and functionality of system

• Process and Instrumentation Drawing (P&ID) created during this phase.

• Bill of Material (BOM) started during this phase


Functional Requirement Specification

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Functional Requirements should include:• Descriptions of operations performed by each

piece of equipment• Descriptions of work-flows performed by the

system• Descriptions of system reports or other outputs• How the system meets applicable regulatory

requirements


• Method of sanitization for pretreatment, primary treatment, storage and distribution systems.

• Ensure materials of construction are suitable for sanitization methods being considered.

• Storage tanks should not be oversized. Allow for peak demands and 2-3 hours of storage.

• Piping distribution loops recirculate continuously at an ideal velocity of 5-7 FT/sec which maintains a turbulent flow and minimizes biofilm build up on the interior pipe walls.

SYSTEM DESIGN CONSIDERATIONS


Process and Instrument Diagram

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Validation

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• Installation Qualification (IQ)The (IQ) execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications

• Operational Qualification (PQ)The (OQ) execution; verifies the equipment , and its ancillary systems or sub systems are operating as described in the FRS

• Performance Qualification (PQ) The PQ is executed over a prescribed period of time by sampling at designated points through the system


Company X

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• Executed protocols (validation) on their own to get more familiar with the equipment

• Created their own PQ• Matrix of sampling• PQ validates the client is making the quality and

quantity of water described in the URS. Comes full circle.

• They maintain all documentation in a controlled area for future audits

System is performing well

upgrading a cosmetic industry water system to meet

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