One of the key elements will be the „Contamination Control Strategy“, based on classical risk management. What seems logical, and is probably already practised in many places, must now be demonstrated in an understandable way. It is a matter of identifying possible contamination risks, assessing them, correcting them if necessary and finally monitoring them continuously.
Humans, as one of the largest sources of contamination in controlled areas, must therefore be specifically considered as part of the required contamination control strategy. Consequently, cleanroom garment, as the only filter between man and the product to be protected, is an essential factor. The same applies to the correct behaviour of personnel in cleanrooms.
Ref.: Guidelines
The Rules Governing Medicinal Products in the European Union – Volume 4 EU guidelines on good manufacturing practice for medicinal products for human and veterinary use Annex 1 Manufacture of sterile medicinal products, Brussels, 22.8.2022 C(2022) 5938 final
Cleanroom garment and New Annex 1
It also seems clear that the New Annex 1 pays more attention to protective clothing suitable for cleanrooms. In particular, a qualification for cleanroom garment is required. The emphasis is increasingly on the requirement that users and operators prove that the cleanroom garment they use guarantees the defined protective properties at all times during the defined period of use. The reason for this is that the regular reprocessing of washable cleanroom garments, i.e. decontamination and, depending on the requirements, sterilisation, has an impact on the properties of the textile and the protective function therefore decreases with the number of use cycles.
From the point of view of the user or the regulatory authorities, the question arises as to how to ensure that, once defined, the clothing system still offers sufficient protection after a certain number of use cycles, in order to properly shield the product from humans, the source of contaminations. In this context, it seems important to us to emphasise the notion of a „cleanroom garment system“. This does not only mean the individual components, but the complete clothing system, i.e. also the undergarments, possible additional components such as disposable face masks, inner hoods, etc., but also the proper preparation, dressing procedures, etc.
Yet how do you achieve this qualification or requalification? This is not an easy task. In order to achieve the objective, the apparel supplier should already be able to provide some empirical data and values and, if possible, not only simply information from the respective manufacturer – because which manufacturer would write „I have a not very good product“? – but ideally data from neutral and recognised test institutes. However, these data are often too general – such as general information on textiles and not on a garment system. When qualifying, the garment system used should be checked as a whole and, if possible, all influencing factors should be taken into account, such as
- duration of wear
- different stress factors in daily use
- possibly different decontamination and sterilisation processes
Another central issue is the question of appropriate measurement methods. In order to be able to classify the measurement results, two essential points must be taken into account:
1. Practical relevance as high as possible.
2. Experience in the field is necessary to interpret the results.
A test facility that is certainly suitable is the so-called „Body-Box“ measurement. However, be careful when comparing measurement results obtained in different measurement setups. Each test setup is different, as each operator of a Body-Box can freely choose where and how to measure in the return air and the air velocity/air change rate. The test person participating in the Body-Box and the movement and measurement programme carried out can differ, amongst other parameters. If microbiological measurement methods are added, the possibilities for variation are also numerous.
We help you to qualify your garment system!
First of all, we have decades of experience in a wide range of testing on the subject of cleanroom garments. The approach of testing a complete clothing system is not new to us: we have been doing it for more than 20 years. We have been operating our Body Box for more than 15 years and have a lot of experience in the field. In addition, we have a large number of other test methods available in our own R&D facilities, for example, for checking the ageing phenomena of cleanroom textiles. Our network and close cooperation with leading research institutes in these fields are other elements that we have available.
Perhaps most importantly, we have already successfully completed qualification studies with international pharmaceutical companies. These studies have not given rise to any remarks during various audits by the authorities and have withstood challenging questions.
We will be happy to help and advise you on the most diverse questions regarding the New Annex 1. Together with you, we will determine what needs to be tested, how and to what extent. We will then carry out the relevant analyses on your behalf and, of course, we will also help you to write the reports and interpret the various measurement data.
Please do not hesitate to contact us!