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PLASTIC PRODUCTS APPLIEDIN LIFE SCIENCE INDUSTRY
WHY CONSIDER PLASTICS?• Why plastic is used  in this industry?        Stainless steel has been used for decades in high-pu...
WHY CONSIDER PLASTICS?• Why plastic is used      Many Pharmaceutical manufacturing methods governed  in this industry?    ...
WHY CONSIDER PLASTICS?• Why plastic is used   WATER FOR INJECTION (WFI)  in this industry?• AGRU material and        USP W...
ESTIMATED INSTALLED COST COMPARISON• Why plastic is used  in this industry?• AGRU material and  products• Requirements• St...
MATERIAL USED IN THE PHARMA INDUSTRY• Why plastic is used   Materials, which do not contain any or only leach-out  in this...
PVDF PIPING• Why plastic is used  in this industry?      Features beneficial for life science industry• AGRU material and ...
PVDF PIPING• Why plastic is used  in this industry?      Pipes, fittings, valves in PVDF-UHP are applied in• AGRU material...
REQUIREMENTS FOR DOKUMENTATION• Why plastic is used  in this industry?        Material / Product approvals (FDA, USP class...
REFERENCES LIFE SCIENCE INDUSTRY• Why plastic is used  in this industry?      References with AGRU products• AGRU material...
ABBREVIATIONS COMMON IN THIS INDUSTY                               CFU …………. Colony Forming Unit• Why plastic is used  in ...
www.agru.atwww.sugison.comwww.grahamika.indonetwork.co.id
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Pharmaceuticals standard piping agru

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Pharmaceuticals standard piping agru

  1. 1. PLASTIC PRODUCTS APPLIEDIN LIFE SCIENCE INDUSTRY
  2. 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. 3
  3. 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 4
  4. 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 5
  5. 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) 6
  6. 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 8
  7. 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. 9
  8. 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 10
  9. 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 16
  10. 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) 19
  11. 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 26
  12. 12. www.agru.atwww.sugison.comwww.grahamika.indonetwork.co.id

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