1. WQA Aquatech USA 2013 • Indianapolis, Indiana
Upgrading A Cosmetic Industry
Water System to Meet USP Purified
Water Standards
Presented by: Chris Gallagher,Mar Cor Purification, Inc.
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2. WQA Aquatech USA 2013 • Indianapolis, Indiana
Standard Disclaimer
The views and theories expressed in the following
presentation represent those solely of the authors, and not
any regulatory, or current or previous manufacturers.

3. WQA Aquatech USA 2013 • Indianapolis, Indiana
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

4. WQA Aquatech USA 2013 • Indianapolis, Indiana
Typical Guidelines
Water Standards / Guidelines
Microelectronics Power ASTM Pharmaceutical
electronics grade
QR 1.2
Type I Type
II
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

5. WQA Aquatech USA 2013 • Indianapolis, Indiana
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

6. WQA Aquatech USA 2013 • Indianapolis, Indiana
Representative Photo of System
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7. WQA Aquatech USA 2013 • Indianapolis, Indiana
SDI Make Up System
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8. WQA Aquatech USA 2013 • Indianapolis, Indiana
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.

9. WQA Aquatech USA 2013 • Indianapolis, Indiana
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
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Resistivity @25°C
(units)
≥1.0 ≥1.0
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Conductivity @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)
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Preventative maintenance schedule and
instructions
To 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
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Piping
(FDA grade, no dead legs)
Required Required

10. WQA Aquatech USA 2013 • Indianapolis, Indiana
• 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

11. WQA Aquatech USA 2013 • Indianapolis, Indiana
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

12. WQA Aquatech USA 2013 • Indianapolis, Indiana
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

13. WQA Aquatech USA 2013 • Indianapolis, Indiana
• 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

14. WQA Aquatech USA 2013 • Indianapolis, Indiana
Process and Instrument Diagram
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15. WQA Aquatech USA 2013 • Indianapolis, Indiana
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

16. WQA Aquatech USA 2013 • Indianapolis, Indiana
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