Sterile disposable microbial air sampler heads ensure new Grade A zero biocontamination limits are met for EU GMP Annex 1
Bicester, UK, 8th March 2022: Cherwell Laboratories, specialists in cleanroom microbiology solutions, is highlighting how SAS Daily Heads are a viable way to help reduce risk and ensure compliance to the new stringent risk management and contamination control strategy within the revised EU GMP Annex 1.
SAS Daily Heads are certified sterile disposable air sampler heads introduced for microbial air sampling applications, where autoclave turnaround times or sterilisation facility validation can prove challenging. The value of these sterile air sampler heads in helping to reduce risk in environmental monitoring (EM) is discussed in a recent blog article available on Cherwell’s website, “How to minimise risk of false positives in EM under the new Annex 1".
Andy Whittard, Cherwell’s Managing Director, commented, “With the new Annex 1 stating a revision to Grade A limits for biocontamination to now be zero, equipment suitability can be a decisive factor in supporting this new tighter limit. We have a range of products and capabilities to support pharmaceutical manufacturers in their environmental monitoring processes through the transition to the revised Annex 1 in preparation for compliance once it is published."
SAS Daily Heads are designed for use with SAS Super, SAS Duo 360 and SAS isolator active air samplers. The SAS range of microbial samplers has long been synonymous with environmental monitoring (EM) within pharmaceutical manufacturing around the world. The distinctive yellow handheld samplers, manufactured in Italy, continue to be distributed and supported in the UK market by Cherwell, building on its 30-plus years of experience gained assisting the UK pharmaceutical industry.
The development of the revised EU GMP Annex 1 has placed not only greater emphasis on continuous monitoring, but also risk assessment tools. The proven SAS samplers are available with reusable stainless steel sampling heads which can be steam sterilised, but this takes time and requires validated sterilisation processes. Daily Heads offer a viable alternative in helping reduce risk. The heads are lot numbered, gamma irradiated, double-wrapped and supplied with a certificate of sterilisation for traceability. They are available in both Contact and Petri dish versions in boxes of 40.
Andy Whittard added, “A critical factor in the effectiveness of EM devices and the production of expensive false positives is the sterility of the sampling head. Daily Heads remove the need for a validated, sterilisation process and substitute this with a certificated sterile product which provides a viable alternative in the quest to reduce risk of false positives.”
Many users are deploying the Daily Heads for sessional monitoring, where the sampler remains in the controlled space. This not only reduces the possibility of any false positive events but reduces transfers in and out of the controlled space. As Daily Heads are manufactured from antistatic plastic resin, they also have the added benefit of improving the handleability of the sampler when operated via glove ports.
Cherwell’s range of SAS samplers is extensive and features not only handheld instruments, but also a specialist unit for Isolator monitoring, the SAS Super Isolator, and a compressed air sampler named Pinocchio. The range also includes the twin head Duo SAS 360 for when dual samples are required at each sample location, such as TVC and mould plate.
All SAS samplers are fully supported by Cherwell’s service department which offers calibration and service for all instruments at its facilities in Bicester, Oxfordshire. Where customers are reluctant to allow their samplers to leave site, Cherwell’s service team can also visit clients’ sites to perform on-site calibrations.
