2. WHY CONSIDER PLASTICS?
• Why plastic is used
in this industry? Stainless steel has been used for decades in high-purity
• AGRU material and
piping systems, but in recent years plastic piping systems
products have gained more market presence in life science
• Requirements industry. Significant potential is still given as worldwide
<5% of systems are currently installed with plastic piping.
• Sterilisation of
pipelines
• References AGRU As a matter of fact:
products
• Abbreviations Nowadays plastic pipes provide lower contamination
and smoother surfaces than the classical stainless
steel systems (also electro polished).
In particular, much lower amount of metal ions
leached to water from high-purity plastic pipes
persuaded some industries, to switch to plastic pipe
solutions.
Today’s state of the art for ultrapure water supply
systems in some industries is PVDF piping.
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3. WHY CONSIDER PLASTICS?
• Why plastic is used Many Pharmaceutical manufacturing methods governed
in this industry?
by USP25 are better handled by the use of thermoplastic
• AGRU material and piping system components
products
• Requirements Pure Water Systems (PW, HPW)
• Sterilisation of Water For Injection (WFI)
pipelines
• References AGRU Clean In Place (CIP)
products
Pure Air and Gas Lines
• Abbreviations
PURE WATER SYSTEMS (PW)
USP Purified Water is required for final dosage for
preparation of any non-parenteral products (non-injected)
Largest market for high performance thermoplastics
plastic (PVDF, PP)
Can be used to feed other systems including WFI
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4. WHY CONSIDER PLASTICS?
• Why plastic is used WATER FOR INJECTION (WFI)
in this industry?
• AGRU material and USP WFI is required for final dosage form preparation of
products any parenteral products (injected)
• Requirements
USP WFI is produced via RO or distillation
• Sterilisation of
pipelines Generally WFI systems is a hot DI system or steam
• References AGRU cleaned system
products
Most critical water system in pharmaceutical industry
• Abbreviations
CLEAN IN PLACE (CIP)
Various forms of system sanitation
Chemical, Ozone, Hydrogen Peroxide...
Caustic cleaning agents are a natural fit for PP pipes and
valves
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5. ESTIMATED INSTALLED COST COMPARISON
• Why plastic is used
in this industry?
• AGRU material and
products
• Requirements
• Sterilisation of
pipelines
• References AGRU
products
• Abbreviations
Total Installed Cost
Including Commissioning
Source:
Estimated cost for installations in North America (acc. USP25 regulations)
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6. MATERIAL USED IN THE PHARMA INDUSTRY
• Why plastic is used Materials, which do not contain any or only leach-out
in this industry?
resistant additives and avoid the growth of
• AGRU material and
products micro-organisms like:
• Requirements
• Sterilisation of PVDF UHP (PVDF Ultra High Purity)
pipelines
• References AGRU PP-Pure (PP-HP grey)
products
• Abbreviations Polypure (PP-natural)
Other AGRU products used in this industry:
ECTFE
Double containment piping system
PVDF and ECTFE for exhaust piping system
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7. PVDF PIPING
• Why plastic is used
in this industry? Features beneficial for life science industry
• AGRU material and
products
Translucent material
• Requirements FM approved material (Fire resistant UL94V-0)
• Sterilisation of
pipelines
Excellent chemical resistance
• References AGRU
(even at high temperature)
products
Excellent mechanical, insulating and
• Abbreviations
biofilm properties
High cleanliness
Lowest leachout
Bead or creaves free joint system available.
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8. PVDF PIPING
• Why plastic is used
in this industry? Pipes, fittings, valves in PVDF-UHP are applied in
• AGRU material and the dimension range OD 20 mm up to OD 63 mm
products (occasionally up to OD 110 mm) in this industry.
• Requirements
• Sterilisation of
pipelines
• References AGRU
PVDF UHP
PVDF UHP Solef
Solef
products
• Abbreviations
Pipe Fitting Valve Custom-
Solef 1010 Solef 1008 Solef 1008 made
products
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9. REQUIREMENTS FOR DOKUMENTATION
• Why plastic is used
in this industry? Material / Product approvals (FDA, USP class VI,
• AGRU material and 3A Sanitary Standards…)
products
• Requirements Complete traceability starting from the resin till the
• Sterilisation of finished product. (works certificate 3.1 acc. EN10204 is
pipelines
required for each product batch)
• References AGRU
products
Production according international standards (EN ISO,
• Abbreviations
ANSI, JIS)
Data log for all joint is including marking of the joints
Training and certification of welders
ISO 9001 quality management from the manufacturer
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10. REFERENCES LIFE SCIENCE INDUSTRY
• Why plastic is used
in this industry? References with AGRU products
• AGRU material and
Pharma / Biotech / Hospitals / Research facilities
products
Pfizer (USA, IRL, SG) USA:
• Requirements - Dartmouth Science Bldg
Glaxo Welcome (UK) - Mallinckrodt Baker
• Sterilisation of
- Genzyme
pipelines Glaxo SmithKline (UK,B) - Ventana Medical
• References AGRU - Amgen
Pepthysintha (B)
products - Women & Infants Hospital
Pharmacie Centrale de L‘Armée (F) - Elan
• Abbreviations
- Merck
Sachem (CN) - Forrest Labs
- John Hopkins Hospital
Lonza (SG)
- Hamilton College
Johnson & Johnson - 4C Clinic VA Mediacl Center
(USA, IRL, Puerto Rico, B, UK, SG) - Wester WA U
- University of Michigan
Wyeth (SG, USA, Philippines) - North Carolina State Vet. Lab.
- University of Wisconsin Biotech. Center
Janssen Pharmaceutica (B)
- Applied Bioscience
Masdar City (Abu Dhabi)
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11. ABBREVIATIONS COMMON IN THIS INDUSTY
CFU …………. Colony Forming Unit
• Why plastic is used
in this industry? cGMP ……….. current Good Manufacturing Practices
• AGRU material and CIP ………….. Cleaning In Place
products EP …………… European Pharmacopeia
• Requirements FDA ………… Food and Drug Administration
• Sterilisation of GMP ………… Good Manufacturing Practice
pipelines
IQ …………… Installation Qualification
• References AGRU
products ISPE ………… International Society of Pharmaceutical
• Abbreviations OQ ………….. Operational Qualification
PQ ………….. Performance Qualification
PW ………….. Purified Water
SIP ………….. Sterilisation In Place
SOP ………… Standard Operating Procedure
USP …………. United States Pharmacopoeia
WFI …………. Water For Injection
DI ……………. Dionisiert Water
HPW ………… High Purified Water
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