IN LIFE SCIENCE INDUSTRYIN LIFE SCIENCE INDUSTRYPLASTIC PRODUCTS APPLIEDPLASTIC PRODUCTS APPLIED
Stainless steel has been used for decades in high-purity piping systems, but in recent years plastic piping systems have gained more market presence in life science industry. Significant potential is still given as worldwide <5% of systems are currently installed with plastic piping.
As a matter of fact:
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.
WHY CONSIDER PLASTICS?WHY CONSIDER PLASTICS?
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
WHY CONSIDER PLASTICS?WHY CONSIDER PLASTICS?
Many Pharmaceutical manufacturing methods governed by USP25 are better handled by the use of thermoplastic piping system components
Pure Water Systems (PW, HPW)
Water For Injection (WFI)
Clean In Place (CIP)
Pure Air and Gas Lines
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 WFI4
• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
WHY CONSIDER PLASTICS?WHY CONSIDER PLASTICS?
WATER FOR INJECTION (WFI)
USP WFI is required for final dosage form preparation of any parenteral products (injected)
USP WFI is produced via RO or distillation
Generally WFI systems is a hot DI system or steam cleaned system
Most critical water system in pharmaceutical industry
CLEAN IN PLACE (CIP)Various forms of system sanitationChemical, Ozone, Hydrogen Peroxide...Caustic cleaning agents are a natural fit for PP pipes and valves
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
ESTIMATED INSTALLED COST COMPARISONESTIMATED INSTALLED COST COMPARISON
Total Installed Cost Including Commissioning
Source: Estimated cost for installations in North America (acc. USP25 regulations) 6
• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
Materials, which do not contain any or only leach-outresistant additives and avoid the growth of micro-organisms like:
PVDF UHP (PVDF Ultra High Purity)
PP-Pure (PP-HP grey)
Polypure (PP-natural)
Other AGRU products used in this industry:
ECTFE
Double containment piping system
PVDF and ECTFE for exhaust piping system
MATERIAL USED IN THE PHARMA INDUSTRYMATERIAL USED IN THE PHARMA INDUSTRY
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
Features beneficial for life science industryTranslucent material
FM approved material (Fire resistant UL94V-0)
Excellent chemical resistance(even at high temperature)
Excellent mechanical, insulating and biofilm properties
High cleanliness
Lowest leachout
Bead or creaves free joint system available.
PVDF PIPINGPVDF PIPING
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
Pipes, fittings, valves in PVDF-UHP are applied in the dimension range OD 20 mm up to OD 63 mm (occasionally up to OD 110 mm) in this industry.
Pipe Solef 1010
Fitting Solef 1008
ValveSolef 1008
SolefSolefSolefPVDF UHPPVDF UHPPVDF UHP
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PVDF PIPINGPVDF PIPING
Custom-made
products
• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
Material / Product approvals (FDA, USP class VI, 3A Sanitary Standards…)
Complete traceability starting from the resin till the finished product. (works certificate 3.1 acc. EN10204 is required for each product batch)
Production according international standards (EN ISO, 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
REQUIREMENTS FOR DOKUMENTATIONREQUIREMENTS FOR DOKUMENTATION
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
References with AGRU productsPharma / Biotech / Hospitals / Research facilities
USA:- Dartmouth Science Bldg- Mallinckrodt Baker- Genzyme- Ventana Medical- Amgen- Women & Infants Hospital- Elan- Merck- Forrest Labs- John Hopkins Hospital- Hamilton College- 4C Clinic VA Mediacl Center- Wester WA U- University of Michigan- North Carolina State Vet. Lab.- University of Wisconsin Biotech. Center- Applied Bioscience
Pfizer (USA, IRL, SG)
Glaxo Welcome (UK)
Glaxo SmithKline (UK,B)
Pepthysintha (B)
Pharmacie Centrale de L‘Armée (F)
Sachem (CN)
Lonza (SG)
Johnson & Johnson(USA, IRL, Puerto Rico, B, UK, SG)
Wyeth (SG, USA, Philippines)
Janssen Pharmaceutica (B)
Masdar City (Abu Dhabi)
REFERENCES LIFE SCIENCE INDUSTRYREFERENCES LIFE SCIENCE INDUSTRY
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• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
ABBREVIATIONS COMMON IN THIS INDUSTYABBREVIATIONS COMMON IN THIS INDUSTYCFU …………. Colony Forming Unit
cGMP ……….. current Good Manufacturing Practices
CIP ………….. Cleaning In Place
EP …………… European Pharmacopeia
FDA ………… Food and Drug Administration
GMP ………… Good Manufacturing Practice
IQ …………… Installation Qualification
ISPE ………… International Society of Pharmaceutical
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 Water26
• Why plastic is usedin this industry?
• AGRU material and products
• Requirements
• Sterilisation of pipelines
• References AGRU products
• Abbreviations
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