Webinar Expert Module 1: Garment Logistics and Gowning. Dupont September GOP-Innovations

Transcription

1 Webinar Expert Module 1: Garment Logistics and Gowning Dupont September 2017 GOP-Innovations your Partner for Practical Training and e-learning

2 Milenko Pavičić Pharmaceutical microbiologist, trainer, coach 10 years of research experience Vrije Universiteit Amsterdam (Medical and Oral Microbiology) Intervet International B.V. (Antibiotics R&D) 18 years of production and QC experience Pharmaceutical companies (NL, B, D, F) Hospital pharmacies (NL, B) Member of the NVZA (Dutch Society of Hospital Pharmacists) work group Microbiology and Hygiene

3 Pavičić Pharmaceutical Microbiology (PPM) and GOP-Innovations Consultancy Courses Practical Training E-learning Aseptic production, Sterilization, Cleaning, Cleanrooms, Disinfection, Microbiology, GMP, Annex 1, Annex 17, QC, Validation, Qualification, Behavior, SOPs, Media fills, Environmental monitoring, Water systems, Sampling, Hygienic Design, EU-GMP, FDA-GMP, EP, USP, Contamination Risk

4 Subjects for today Garment logistics in pharmaceutical companies Gowning procedures for the different grades of pharmaceutical cleanrooms Gowning qualification and monitoring

5 Garment logistics in pharmaceutical companies

6 Garments, gloves, sleeves, goggles and other sterile accessories Single packed (grade D) Individually double packed (grade C and A/B) Individually double packed with several units (e.g. 5) in a third clean or sterile packaging (grade A/B) Multiple units in a clean protective bag in a plastic* or cardboard** transport box *: reusable garments **: disposable garments

7 Footwear Cleanroom (safety) shoes Cleanroom (safety) clogs Shoecovers

8 Other things present in a Hand disinfectant personnel airlock Disinfectant (e.g. sterile 70% alcohol) for surface disinfection Sterile wipes Sterile gloves Sterile mouth masks Sterile sleeves Sterile goggles

9 Garment logistics Transport to company Storage in warehouse Transport to department Storage in area or cabinet outside cleanroom Storage in rack or open cabinet in personnel airlock Disposal of waste (e.g. packagings, gloves, mouth) Collection of used garments Transport of used garments to laundry service

10 Gowning procedures for the different grades of pharmaceutical cleanrooms

11 How to enter the production facility? from outside to grade D Take off own clothes and shoes Wash and dry hands Go to the clean zone Put on grade D garment or cleanroom undergarment for grade C or grade A/B Put on head cover Put on cleanroom shoes or clogs Disinfect hands

12 How to enter the production facility? to grade C Condition: you wear grade D garment Disinfect hands Put on grade C garment Put on grade C shoes, clogs or cleanroom boots Disinfect hands Option: put on a sterile mouth mask Don sterile or clean non-sterile disinfected gloves

13 Basic design of gowning areas example of entrance to grade C and D Grade D Grade C Grade D Grade C Step over bench CNC Grade D

14 How to enter the production facility? to grade A/B Condition: you wear cleanroom undergarment Wash and disinfect hands Change shoes or put on shoe covers Disinfect hands Don sterile gloves Put on grade A/B garment

15 Basic design of gowning areas example of entrance to grade A/B Clean buffer zone (no activity) Put on cleanroom boots Put on mouth mask, cleanroom garment and goggle Grade B Don second pair of sterile gloves Grade B Grade C Grade D Disinfect hands Disinfect hands and don sterile gloves Grade C Collect garment, goggle, gloves, mouth mask Change shoes or clogs or put on shoe covers

16 How to leave the production facility? Grade C or D: take off the cleanroom garment and hang it in the personnel airlock for reuse Grade A/B: take off the cleanroom garment in het last part (grade D or CNC) of the airlock to prevent contamination Garments for grade A/B may not be reused

17 EU-GMP (1) Personnel 43. The description of clothing required for each grade is given below: Grade D: Hair and, where relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area. Grade C: Hair and where relevant beard and moustache should be covered. A single or two-piece trouser suit, gathered at the wrists and with high neck and appropriate shoes or overshoes should be worn. They should shed virtually no fibres or particulate matter.

18 EU-GMP (2) Personnel Grade A/B: Headgear should totally enclose hair and, where relevant, beard and moustache; it should be tucked into the neck of the suit; A face mask should be worn to prevent the shedding of droplets. Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibers or particulate matter and retain particles shed by the body.

19 EU-GMP (3) Personnel 44. Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. For every worker in a grade A/B area, clean sterile (sterilised or adequately sanitised) protective garments should be provided at each work session. Gloves should be regularly disinfected during operations. Masks and gloves should be changed at least for every working session.

20 EU-GMP (1) Premises 51. Changing rooms should be designed as airlocks and used to provide physical separation of the different stages of changing and so minimize microbial and particulate contamination of protective clothing. They should be flushed effectively with filtered air. The final stage of the changing room should, in the at-rest state, be the same grade as the area into which it leads. The use of separate changing rooms for entering and leaving clean areas is sometimes desirable. In general hand washing facilities should be provided only in the first stage of the changing rooms.

21 EU-GMP (2) Premises 52. Both airlock doors should not be opened simultaneously. An interlocking system or a visual and/or audible warning system should be operated to prevent the opening of more than one door at a time.

22 PDA: Points to consider for aseptic processing (2015)

23 Gowning procedure (1) EU-GMP grade A/B areas

24 Gowning procedure (2) EU-GMP grade A/B areas

25 Gowning procedure (3) EU-GMP grade A/B areas

26 Gowning procedure (4) EU-GMP grade A/B areas

27 Gowning procedure (5) EU-GMP grade A/B areas

28 Gowning procedure (6) EU-GMP grade A/B areas

29 Gowning procedure (7) EU-GMP grade A/B areas

30 Gowning procedure (8) EU-GMP grade A/B areas

31 Gowning procedure (9) EU-GMP grade A/B areas

32 Gowning procedure (10) EU-GMP grade A/B areas

33 Gowning procedure (11) EU-GMP grade A/B areas

34 Gowning procedure (12) EU-GMP grade A/B areas

35 Gowning procedure (13) EU-GMP grade A/B areas

36 Gowning procedure (14) EU-GMP grade A/B areas

37 Gowning procedure (15) EU-GMP grade A/B areas

38 Gowning procedure (16) EU-GMP grade A/B areas

39 Gowning procedure (17) EU-GMP grade A/B areas

40 Gowning procedure (18) EU-GMP grade A/B areas

41 Gowning qualification and monitoring

42 EU-GMP cleanroom specifications and limits Particles Viable microorganisms (expressed as CFU)

43 US-GMP cleanroom specifications and limits Grade A Grade B Grade C

44 Gowning Qualification grade A/B areas Gowning training Initial gowning qualification: 3 times Requalification: varies from quarterly to annually and in case of limit excursions Objective (checklist) visual examination of execution of cleanroom gowning Microbiological sampling of gown (head, trunk, arms, legs), gloves, goggle, face mask

45 Personnel Monitoring grade A/B areas After interventions in grade A: sampling of gloves At exiting the grade A/B area: sampling of representative locations on the gown, gloves, goggle, face mask Periodic unannounced visual inspection of gowning

46 Sampling of garments grade A/B example Goggle Front near zipper Hood front top Hood side Face mask Front Back Sleeves L+R Gloves L+R Legs L+R Boots L+R Black + Blue: Gowning Qualification Blue: Gown Exit Monitoring

47 Typical Microbiological Quality qualification and monitoring Hood: 5 CFU/contact plate* Chest: 5 CFU/contact plate* Legs, boots: 5 CFU/contact plate Goggle: 5 CFU/contact plate* Face mask: 5 CFU/contact plate* Forearm: 1 CFU/contact plate Gloves: < 1 CFU/glove (= 5 fingers) *: Many companies apply more strict limits, e.g. 2 CFU/contact plate

48 Sampling of gowns and gloves Sampling of the gown should be executed near the area exit People should leave the production area after sampling of the gown People should change gloves after glove sampling

49 Gowning Qualification grade C and D areas Gowning training Initial gowning qualification Objective (checklist) visual examination of correct execution of cleanroom gowning