Fabric & Finishes. Gordon Farquharson July 2017

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1 Fabric & Finishes Gordon Farquharson July 2017

2 Every Cleanroom is a Prototype!! Process & Product has unique features The building and its environment are unique The equipment configuration is unique The project team is unique BUT All cleanrooms use common components and techniques Slide 2 PharmOut 2017

3 Cleanrooms are very different! Cleanroom technology applied to API manufacture Slide 3 PharmOut 2017

4 Cleanrooms are very different! Formulation equipment Slide 4 PharmOut 2017

To maintain ISO cleanliness Classes (1-9), or GMP Grades (A-D). 3. Containment of hazards arising from the process. 4.

5 Role of the Cleanroom 1 1. Exclusion of the external environment. 2. To create the class of cleanliness required for the process by dilution or displacement of the contamination generated. To maintain ISO cleanliness Classes (1-9), or GMP Grades (A-D). 3. Containment of hazards arising from the process. 4. Control of Process-to-Process cross-contamination. A Pharma GMP issue. 5. Control and management of Personnel flow and procedures by way of planning and layout of the suite. Way IN ==> Way Out. Slide 5 PharmOut 2017

6 Role of the Cleanroom 2 Role Control and management of Material flow by way of planning and layout of the suite. To create optimum conditions for the process, including special requirements such as Low %RH; special illumination conditions; etc. To accommodate the process equipment in a safe and effective way. To allow effective monitoring of the controlled environment created in the cleanroom suite. Slide 6 PharmOut 2017

7 Configuration of clean rooms Slide 7 PharmOut 2017

Design layout Planning and layout requirements are not defined in GMPs. The expectation however, is quite clear. The layout and planning should ensure the following: 1.

8 Design layout Planning and layout requirements are not defined in GMPs. The expectation however, is quite clear. The layout and planning should ensure the following: 1. Effective segregation between the external environment and the classified space. 2. Well managed materials and personnel flow. 3. Segregation spaces of different grade or class. Slide 8 PharmOut 2017

9 Don t underestimate the impact of the process equipment Slide 9 PharmOut 2017

10 The potential of closed process equipment CIP/SIP uncontrolled area vacuum classified area heating cooling uncontrolled area Slide 10 PharmOut 2017

11 Designing for adaptability Loose fit - enables changes with minimum disruption Consider modular design Service chases Clean construction protocol ISO External access for maintenance Slide 11 PharmOut 2017

12 Loose Fit Design Concepts Service Zone Concept Plan Unclassified Technical Support Area Process Area B Process Corridor B Slide 12 PharmOut 2017

13 Loose Fit Design Concepts Service Chase Concept Plan - Microelectronics Unclassified Technical Support Area Process Area B Process Corridor B Slide 13 PharmOut 2017

14 Corridors and working spaces Slide 14 PharmOut 2017

15 Remember maintenance of technical systems Slide 15 PharmOut 2017

16 Construction of clean rooms Some images from MRC Systems & Clestra Slide 16 PharmOut 2017

17 Basic construction methods GMP doesn t mandate any specific approach. 1. Stick-built. In-situ construction Masonry + gypsum applied plaster + applied finish Gypsum or calcium silicate board + closing of joints + applied finish Finish options: Sheet PVC Sprayed elastomeric paint Epoxy paint Finish options: Sheet PVC Sprayed elastomeric paint Epoxy paint 2. Pre-fabricated, pre-finished cleanroom wall & ceiling systems Options Mild steel painted Stainless steel GRP Glass reinforced polyester Phenolic sheet Slide 17 PharmOut 2017

18 Choosing the preferred option Cost Shouldn t always be at the top of the list. Remember you should be considering >20 years life. Local sourcing Materials Labour to install Technical support Construction environment Clean/dirty - Dry/wet Project lead times and decision making Have to make decisions early for pre-fabricated Have longer to cogitate for stick-built Modification and relocation requirements Is the systems compatible with development and evolution of the business operations? Repair In house / Local resources Vendor dependent Slide 18 PharmOut 2017

19 Other attributes of the construction system Ceiling: Suspended Bridging on walls Walk-on Low level return air ducts: In wall construction Double wall required Plant on surface Services in walls: In wall thickness In a service pod on wall In a service chase Slide 19 PharmOut 2017

20 Masonry System Slide 20 PharmOut 2017

21 Masonry walls Concrete ceiling Hard plaster (gypsum) Door frames set into the wall structure Applied epoxy paint to walls Thin epoxy floor finish Slide 21 PharmOut 2017

22 Gypsum Board and Frame System Metal frame Calcium silicate or Gypsum board attached Joints taped Finish applied this case a glass reinforced polyester resin. Slide 22 PharmOut 2017

23 GRP Cleanroom System Slide 23 PharmOut 2017

24 Slide 24 PharmOut 2017

25 Typical metal panel system Slide 25 PharmOut 2017

26 Floor channels... Slide 26 PharmOut 2017

27 Ceiling channels... Slide 27 PharmOut 2017

28 Single or double glazing Slide 28 PharmOut 2017

29 Doors Swing Slide Powered Slide 29 PharmOut 2017

Doors should be self closing (soft close to avoid pressure shocks). 4. Hygienic design. Avoid cavities and ledges.

30 Door attributes 1. Swing doors should close with air pressure. 2. Often need to work with electromechanical interlock systems 3. Doors should be self closing (soft close to avoid pressure shocks). 4. Hygienic design. Avoid cavities and ledges. 5. Powered doors Becoming more common Ensures optimum open/close rate Can help avoid hand contact 6. Sliding doors OK Ensure cleanroom style Avoid floor tracks Ensure top track cleanable Slide 30 PharmOut 2017

31 Integration of process and services FLUSH with the panel Slide 31 PharmOut 2017

32 Walk-on ceiling Slide 32 PharmOut 2017

33 Cleanroom flooring (1) Sheet materials adhered to floor: PVC sheet (lowest cost) Adhered to floor. Seams welded Cove former to walls Tacky mats Permanent Peel-off Slide 33 PharmOut 2017

34 Cleanroom flooring (2) Applied screeds 1. Epoxy (thin self levelling) Available in ESD/static dissipative and conductive versions. 2. Polyurethane (thin self levelling) Some uses the natural power of silver to fight bacteria, and Available in ESD/static dissipative and conductive versions. 3. Epoxy terrazzo (thick) recycled granular material. 4. Tiles Ceramic (chemical plants) Epoxy Terrazzo Slide 34 PharmOut 2017

disinfectant materials. Routine hygiene and cleanliness monitoring 2.

35 Cleanroom flooring (3) Cleaning 1. Classified cleanrooms Surface swabbing with mops and controlled disinfectant materials. Routine hygiene and cleanliness monitoring 2. Non-sterile manufacturing Machine cleaning preferred Periodic housekeeping controls. Slide 35 PharmOut 2017

36 Equipment integration Slide 36 PharmOut 2017

37 Equipment integration Slide 37 PharmOut 2017

38 Thank you for your time. Questions? Gordon Farquharson Executive Consultant Slide 38 PharmOut 2017

2. In moist areas, portland cement plaster should be used if a more permanent material is not within budget limits.

2. In moist areas, portland cement plaster should be used if a more permanent material is not within budget limits. UDIVISION 9 FINISHES 09 00 00 FINISHES 09 20 00 PLASTER AND GYPSUM BOARD PLASTER 1. Major partitions are to extend to underside of structure as required by code. Allow for structural deflection. Provide