Pharmaceuticals standard piping agru

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


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



• Requirements



• Abbreviations


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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• Requirements



• 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



• Requirements



• 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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• Requirements



• 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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• Requirements



• 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



• Requirements



• 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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• Requirements



• 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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• Requirements



• 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



• Requirements



• Abbreviations

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Pharmaceuticals standard piping agru

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