GMP WASHING FOR BIO-PHARMA PRODUCTION.

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1 GMP WASHING FOR BIO-PHARMA PRODUCTION

2 AGENDA Intro to GETINGE Why GMP Washing? Where GMP Washing? Not all washers are GMP capable. GMP and LAB washers. Specific characteristics of GMP washing Hardware Documentation Racks ( Personal favourite!)

3 Getinge Group in brief A truly global company

4 Getinge Life Science

5 Getinge Life Science Product portfolio 5

6 GMP WASHING WHY AND WHERE?

7 Why is cgmp cleaning required? Original emphasis was to prevent cross contamination between: Non-penicillin drug products and penicillin drug products Drugs with potent steroids or hormones 1963 GMP regulations (part 133.4) required that equipment shall be maintained in a clean and orderly manner 1978 (211.67) updated the previous version and is still the basis of design today CFR: Code of Federal Regulation, acts as the force of law behind GMP

8 Why is cgmp cleaning required? Reasons why GMP cleaning in pharmaceutical facilities is important: 1. To prevent contamination of drug product during manufacturing. 2. To prevent cross-contamination between different batches. 3. To prevent cross-contamination between different products within same facility. 4. To ensure quality, effectiveness and safety of drug product. 5. To protect patient s health: «Poor CGMP conditions at a manufacturing facility can ultimately pose a lifethreatening risk to a patient.» Guidance Industry Current Good Manufacturing Practice (September 2004)

9 Why is cgmp cleaning required? Local/National Drug Authority (eg. US FDA) is entitled to close/suspend manufacturing process within a facility. Random inspections of all aspects of the production cycle. Cleaning process is part of the production cycle! Most common inspection issues: Lack of process validation Lack of cleaning validation (SOPs)- Specially manual cleaning. Lack of QC lab controls Acceptable level criteria ANVISA?

10 Fields of applications BIO-PHARMACEUTICAL PRODUCTION has many areas and support facilities for each pharmaceutical type and its manufacturing process: Injectables: vials, ampoules, syringes Other liquid forms: syrups, liquid drops Semi-solid forms: suppositories, gels, creams Solid forms: tablets, capsules, effervescent tablets Biologicals is specialy important!

11 Fields of applications In Research and Development Departments: Formulation and scale up (a.k.a. Pilot Plants) in manufacturing and packaging Analytical development in quality control department Laboratory or GMP washing??

12 Items to be processed Formulation Filling Finishing Same equipment and tools for all pharmaceutical forms that need to be cleaned: Glassware (erlenmeyer flasks, volumetric flasks, pipettes) Nalgene bottles Shovels, spatulas, stirrers Containers, drums Tools (funnels, buckets, scissors, etc.) Balances Trays

13 Items to be processed Formulation Filling Finishing Raw material is mixed in one or several steps Liquid and Semi-Liquid forms by mixing only: - Shipping vessels - Pressure cans - Flexible hoses - Stainless steel tubes - Manifolds Solid by mixing only or by granulation with a solvent or liquid : - Filter housing - Tanks - Tri clamps - Valves - Grinders

14 Items to be processed Formulation Filling Finishing Tablets / Capsules Pumps Valves Hoppers Manifolds Pistons Different parts of the production machines Active Parts: Punches, pistons,trays, etc. Tools used to dismantle the machines

15 Items to be processed Formulation Filling Finishing Filling and Finishing made in one step Liquids/injectables: ampoules, vials, bottles Clean glassware before being sterilized and/or filled (bottles, vials) for Injectables Different active parts of machines : -Pumps -Valves -Hoppers Semi-solids: tubes, plastic strips - Injection needles - Manifolds - Pistons - Trays Other parts of the production machines Tools used to dismantle the machines

16 Items to be processed Formulation Filling Finishing Primary packaging area: Types: - Plastic tubes - Blister packs - Strip-seals To be washed: - Hoppers - Conveyors - Guides - Slides - Other parts of machine - Tools etc.

17 GMP AND LAB WASHERS Different designs for different cleaning requirements

18 What is a GMP compliant washer-dryer? Design philosophy: NO WATER RETENTION + ALL DOCUMENTED Quality of surfaces, welds, connections, components Accurate monitoring of all critical parameters Traceability of construction materials and operations Compliant to applicable regulations (ASME-BPE, 21 CFR part 211, etc.)

19 Hydraulic design GMP WASHER LAB WASHER Orbital welding used for piping (no retention due to weld seams) No orbital welding piping may be square/rectangular or even flexible hoses Dead legs ratio of 3D for piping No specified ratio for dead legs Water feeding pipe sloped to chamber Use of flexible hoses + threaded connections for water connection High grade sanitary recirculating pump Industry standard pump meant for extensive & intensive use

20 Different racks/baskets GMP WASHER LAB WASHER

21 Mechanical design GMP WASHER LAB WASHER INTERNAL welding of chamber EXTERNAL welding of chamber Weld polishing with Ra < 0.6 µm Weld polishing not applicable All high-grade 316L stainless steel including outer panels 316L stainless steel used for chamber only Use of air-actuated sanitary valves for air & water Use of electrical valves for water No drain pump gravity drain only Drain pump = standard Gravity drain = option

22 Chamber construction Polished weld Non-polished weld

23 Control system GMP WASHER LAB WASHER Use of 21 CFR part 11 compliant PLC No requirement for electronic signature or any similar kind of compliance Siemens S7 PLC (most popular) and Rockwell AB PLC Mostly simple PCB controlled equipment Possibilites of data exchange table (eg. SCADA type), data recording & collection Data recording and collection only via printer

24 Control system GMP WASHER LAB WASHER

25 GMP WASHER IMPORTANT CHARACTERISTICS

26 GMP washer-dryers important characteristics

27 GEW cgmp washer functions TACT cleaning methods 4 cleaning methods 1. TIME: Wash exposure period 2. ACTION: Mechanical impingement provided by main pump 3. CHEMICAL: Appropriate cleaning solution(s) to break bonds of soil 4. TEMPERATURE: Wash Solution heated to assist cleaning GMP Washers are specially designed to have no retention areas, better surface finishes, and better materials to eliminate contamination and crosscontamination. Providing clean and DRY products.

28 Chamber sizes P Pit or floor mounted

29 Prewash 1 Prewash 2 Prewash 3 Wash Rinse A Acid rinse Rinse B Rinse 1 Rinse 2 Rinse 3 Rinse 4 Final rinse Super drying Cooling Adjustable recipe (wash cycle) overview The steps are always launched in this order. If the recycling period is not programmed, the next step is automatically tested. STEP OPTIONS DISPLAYED Unit Range Recycling mm:ss 0-29:59 Water - HWFI/CWFI Detergent quantity ml Acid quantity ml Temperature C 0-95 Number 1-9 Conductivity check ms/cm Conductivity check µs/cm Period mm 0-90 Temperature C 0-110

30 Water pump Power Pump close-coupled with washer chamber = maximum efficiency Pump outlet vertical (mfr recommended) Advantage: Significantly higher flow rates (up to 46% in some cases!)

31 Footprint Chamber volume/footprint Flexible service access Innovative door designs «Walk-in» trolleys: space saving and ergonomic

32 Service access and utilities Advantage: Full front OR side service access and flexible utilities locations Flexible service access Full front: service (slideout electrical) Load side Mirror image configurations standard Cross-contamination barrier Full side: service (swingout electrical) Unload side Utilities from top or either side

33 Compliance and standards ASME BPE 2009 FULL compliance Full traceability Components, tubing, fittings Surface finishes USP Class VI Elastomers Traceability GAMP 5 Guidelines Documentation Programming

34 Construction features Industry standards utilized: orbital welding and tri-clamp fittings Self cleaning: piping and components positioned for complete drainage Maximized slopes Minimum dead legs High surface finish No threads

35 Controll system Allen Bradley, Siemens, control systems available Various touch screen panel sizes Panel mounted printer Ethernet data integration Intuitive GUI screens common across platforms

36 Components Industry standard Globally available Non-proprietary components and instruments ASME BPE 316L SS components and piping USP Class VI elastomers Customer-specified components available

37 Documentation Documentation GAMP 5 guidelines: life cycle approach Submittal package for approval as-built TOP documents program source code Electronic standard, paper available

38 Spray coverage Square chamber Spray arm with sprayball ends, top and bottom of chamber Load capacity with 2-Level washing Larg pump HP, 265 to 315 gpm flow, vert. outlet

39 Wash monitoring Different options Glass door to load viewing- Visual Spray arm rotation monitoring- Process control Pump pressure transmitter- Process control Pump mass flow- Process control

40 GEW model features Basis of design Delivery: Flow into chamber is verified during delivery Isolation valve at chamber wall rinsed by lower spray arm Monitoring: Pressure transmitter Conductivity monitoring Flowmeter, volumetric delivery Mass flow, v/v verification versus water intake

41 Drying Drying coverage Drying path: Chamber drying: outside of parts and glassware Column drying: inside of parts and glassware Identical and independent systems Drying efficacy: Temperature (Up to 110 C) Flowrate: 170 to 300 cfm = no exhaust fan necessary HEPA filtration (dual) Monitoring: Independent P of HEPA s Independent RTD s DOP ports standard Fans/heaters elec. interlocked

42 INTELLI-RACK LOADING EQUIPMENT Racks and baskets

43 IntelliRack - modular & custom wash racks Versatile, sanitary, multi-level washing Modular racks for most common applications Easy selection based on size of glassware Modules interchangeable on base racks Ergonomic handling and storage Integral support grids, hold down screens and sprayballs as necessary per application Customized racks available with Getinge parts modeling service

44 Design-build method Parts inventory Capture geometric data Getinge exclusive: parts modeling service using high precision coordinate measuring machine Create 3D parts models Final product 3D rack model Approval drawing

45 Modular rack 4 quadrants Modular rack base (4 quadrants) Modular rack base (4 modules loaded)

46 Rack modules light and flexible solutions

47 Filling line modules Pumps assembly module Unladen weight : 2.3kg Estimated weight with parts : 3.5kg Pumps assembly module Unladen weight : 1.9kg Estimated weight with parts : 2.7kg

48 Glassware, hoses, and flat modules Glass vessel module Unladen weight : 2.4kg Estimated weight with parts : 8.8kg Basic module Unladen weight : 1.02kg Estimated weight with parts : 1.3kg Hoses module Unladen weight : 2.1kg Estimated weight with parts : 2.8kg

49 Modules for every application

50 Questions November 27, 2013

51 THANK YOU

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