Good Cleanroom Design & Construction Practice. Presented by Gordon Farquharson July 2017

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1 Good Cleanroom Design & Construction Practice Presented by Gordon Farquharson July 2017 Slide 1 PharmOut 2017

Agenda Good Design & Construction Practice Cleanrooms Based on the scope and intents of the revised edition of ISO 14644-4 Design, Construction & Start-up due

2 Agenda Good Design & Construction Practice Cleanrooms Based on the scope and intents of the revised edition of ISO Design, Construction & Start-up due in ISO Link to Annex 15 of the PIC/S GMP Guide. Some new energy saving considerations. Practical tips the devil is in the details. Slide 2 PharmOut 2017

3 ISO :2001 and NEW Adequate space. Specify ISO cleanliness class. Clean construction protocol. Avoid cracks, crevices, and uncleanable areas. Impervious, non-shedding surfaces. Coved junctions. Guidance on air changes/hr for non-udf. Design review and testing fits with old Annex new aspects Generally updated. Air change rates guidance removed; source strength of contaminants and ventilation effectiveness principles included. Energy saving measures identified. URS added to link to new Annex 15 PIC/S GMP guide. Slide 3 PharmOut 2017

4 Every Cleanroom is a Prototype!! Process & Product has unique features The host building and its environment are unique The equipment configuration and layout is unique The project team is unique BUT All cleanrooms use common components and techniques Slide 4 PharmOut 2017

5 Cleanrooms are very different! Cleanroom technology applied to API manufacture Slide 5 PharmOut 2017

6 Cleanrooms are very different! Formulation equipment Slide 6 PharmOut 2017

7 Role of the Cleanroom 1 1. Exclusion of the external environment. 2. To create the class of cleanliness and environmental conditions 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 Material & Personnel flows and procedures by way of planning and layout of the suite. Slide 7 PharmOut 2017

8 Configuration of Clean Rooms Slide 8 PharmOut 2017

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

9 Design Layout Planning and layout requirements are not defined in GMPs or Cleanroom standards. 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 9 PharmOut 2017

10 Don t Underestimate the Impact of the Process Equipment Slide 10 PharmOut 2017

11 The Potential of Closed Process Equipment CIP/SIP uncontrolled area vacuum classified area heating cooling uncontrolled area Slide 11 PharmOut 2017

12 Designing for Adaptability Loose fit - enables changes with minimum disruption Consider modular design Service chases Clean construction protocol ISO External access for maintenance Slide 12 PharmOut 2017

13 Corridors and Working Spaces Slide 13 PharmOut 2017

14 Remember Maintenance of Technical Systems Slide 14 PharmOut 2017

15 Construction of clean rooms Some images from MRC Systems & Clestra Slide 15 PharmOut 2017

16 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 panel systems Options Mild steel painted Stainless steel GRP Glass reinforced polyester Phenolic sheet Slide 16 PharmOut 2017

17 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 17 PharmOut 2017

18 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 18 PharmOut 2017

19 Masonry System Slide 19 PharmOut 2017

20 Masonry walls Concrete ceiling Hard plaster (gypsum) Door frames set into the wall structure Applied epoxy paint to walls Thin epoxy floor finish Slide 20 PharmOut 2017

21 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 21 PharmOut 2017

22 GRP Cleanroom Panel System Picture courtesy of MRC Systems Ltd Slide 22 PharmOut 2017

23 Typical Metal Panel System Slide 23 PharmOut 2017

24 Floor Channels... Slide 24 PharmOut 2017

25 Ceiling Channels... Slide 25 PharmOut 2017

26 Walk-on Ceiling Slide 26 PharmOut 2017

27 Single or Double Glazing Slide 27 PharmOut 2017

28 Doors Swing Slide Powered Slide 28 PharmOut 2017

Doors should be self closing (soft close to avoid pressure shocks). 4. Hygienic design. Avoid cavities and ledges. 5.

29 Requirements - 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 29 PharmOut 2017

30 Door Options Hinged Horizontal sliding Vertical roller door Slide 30 PharmOut 2017

More convenient for moving materials & equipment (pallets, IBCs).

31 Advantages of Sliding Doors Saves space (in particular in clean corridors for Grade C & D areas). No wind effect when opening & closing. More convenient for moving materials & equipment (pallets, IBCs). Less susceptible to mechanical damage. More convenient for large openings. Can be part opened. Slide 31 PharmOut 2017

32 Disadvantages of Sliding Doors Sometimes greater cost than double leaf swing door. Top track needs periodic inspection. Not good for dusty rooms should be on clean corridor side. FactoryTalk May-15 Slide 32 PharmOut 2017

33 Doors in OSD Application -With Airlock Clean process corridor Process Room Process Room + Slide 33 PharmOut 2017

34 Doors in OSD Application Without Airlock Clean process corridor ++ Process Room + Process Room + Slide 34 PharmOut

35 Sliding Doors in OSD Cleanroom Example MSD Singapore Slide 35 PharmOut 2017

36 Sliding Door Details Very important to choose specialist good supplier. Essential Top track, door leaf, and bottom guide. Slide 36 PharmOut 2017

37 Single Door Width Slide 37 PharmOut 2017

38 Insulated Sliding Doors Cold Room Slide 38 PharmOut 2017

39 GRP Sliding Doors Slide 39 PharmOut 2017

40 Glass & Low Leakage Sliding Doors Slide 40 PharmOut 2017

41 Door Leakage Generally some leakage is OK. Should be estimated and allowed for. If cleanrooms are too airtight, pressure balancing and pressure stability become problematic. Example SP 30 +/-3 Pa Slide 41 PharmOut 2017

42 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 42 PharmOut 2017

43 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 43 PharmOut 2017

disinfectant materials. Routine hygiene and cleanliness monitoring 2.

44 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 44 PharmOut 2017

45 Equipment Integration Space for the equipment. Integration with the room fabric. Maintenance access. Room Pressure barriers. Slide 45 PharmOut 2017

46 Equipment Integration Room Pressure barriers. Impact of equipment on room pressure due to air in-flow (loss) into the equipment. Slide 46 PharmOut 2017

47 Thank you for your time. Questions? Gordon Farquharson Executive Consultant Slide 47 PharmOut 2017

TGA GMP cannabis facility considerations

TGA GMP cannabis facility considerations Trevor Schoerie - Managing Director August 2018 Slide 1 PharmOut 2018 Typical Engineering Project Presented by Trevor Schoerie 8 August, 2018 XXYYZZ_XXX Architectural