In this article, we move onto the personnel section, section 7.
The section starts with reminding us about having sufficient trained and experienced personnel but with the focus on manufacture and testing of sterile products, and any of the specific manufacturing technologies used in the site’s operations.
The requirement to minimise numbers in clean rooms now links to setting the maximum numbers based on the risk, aseptic process simulations as well as during qualification.
Significantly more emphasis is now placed on training. Gowning qualification is needed for those entering cleanrooms as well as training related to the protection of sterile products for those operators entering the grade B cleanrooms and/or intervening into grade A. Gowning should be assessed and re assessed at least annually, to verify compliance. This should be by visual and microbiological means. Only those that meet the qualification requirements should be permitted into grade A and grade B areas without the need for supervision.
Training should, for example, involve cleanroom practices, contamination control and aseptic techniques. The personnel accessing grade A and B areas should be trained for aseptic gowning and aseptic behaviours. The level of training should be based on the criticality of the function and area in which the personnel are working. By exception only and following a documented procedure should unqualified personnel be allowed into grade A and B areas and only then under supervision.
Furthermore, unacceptable outcomes to assessments, adverse trends in personnel monitoring or implicated in the root cause of a media fill failure should invoke a disqualification procedure. Re-instatement should then only be possible follow successful reassessment.
Supporting the traditional cleanroom entry procedures such as removing jewellery, Annex 1 now recognises developing trends. Mobile devices, phones and tables,for example, are not permitted unless issued by the company and are indeed necessary for the work being undertaken. Over many years the understanding of “No outdoor clothing in grade B/C areas” has changed. The new annex 1 makes the expectation very clear by stating:
“Outdoor clothing including socks (other than personal underwear) should not be brought into changing rooms leading directly to grade B and C areas.”
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this, he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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Garments should be checked for integrity before packing and sterilization and the pack integrity checked before opening. Garments should be visually checked for cleanliness and integrity immediately prior to and after gowning as well as at the end of each session. Adequate sterilization processes should be confirmed where garments are intended to be sterile. Unless disposable, garments should be replaced at a defined frequency. While much of the garment criteria for each grade remains, unchanged there are notable additions in the new annex. For example, grade B access requirements, a suitable dedicated under garment below the sterile garment. Garments should be of an appropriate size. Sterile donning gloves worn, and a second pair worn with the sleeves tucked in between the donning and top gloves. Facility approved socks are required as are sterile eye coverings and sterile footwear. Garments be packed with aseptic donning considerations before sterilization. Garment qualification should define the maximum exposure time for the garment before it needs to be replaced. During use, gloves should be regularly disinfected, and garments must be immediately replaced on the detection of damage.
The role of laundry facilities has also been expanded such that garment laundering should use a qualified process (including the number of permitted washing and sterilization cycles) ensuring that the clothing is not damaged or contaminated by fibres or particles during the repeated laundry process. Laundry facilities used should not introduce risk of contamination or cross-contamination. After washing and before packing, garments should be visually inspected for damage and visual cleanliness.
The final part of section 7 is about behaviours. Movement should be minimised to reduce shedding from over vigorous activity. Aseptic operations should use techniques to prevent changes in air currents that may introduce air of lower quality into the critical zone.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
