FDA inspectors are getting tough on procedures that show protective goggles used in cleanrooms are both fit for purpose and have the required cleaning and sterilisation process documentation. Berendsen highlights what pharmaceutical manufacturers’ responsibilities are
In a warning letter to a manufacturer of pharmaceuticals, the US Food and Drug Administration (FDA) warned that the cleaning and disinfection process for goggles used in aseptic cleanrooms could not guarantee sufficient protection to eliminate contamination. The regulatory authorities require fully documented validation studies resulting in effective and reproducible processes.
Documented methods scrutinised At an inspection of a major pharmaceutical manufacturer, the US health and safety regulator observed and commented in a warning letter that ‘Operators working inside the aseptic core during the manufacture of [x], were wearing goggles that had not been adequately sterilised …’
The cleanroom goggles worn in the Class 100 area (equivalent to ISO 5 or GMP Class A) had been sanitised by the manufacturer, but not sterilised. In the warning letter the FDA required the manufacturer to document the cleaning process using a FDA qualification study with a colony forming unit (cfu)/contact plate of Aspergillus brasiliensis and <(b)(4) cfu/contact plate for all other organisms.
The FDA made it clear that it is the pharma manufacturer’s responsibility to demonstrate that its goggles have an appropriate design and that those used in an ISO 5 environment are not a possible source for contamination.
With this in mind, cleanroom owners should re-evaluate the current usage of cleanroom goggles, not only to see if the design of the goggles lives up to FDA scrutiny, but also if the cleaning and disinfection process can fulfil FDA requirements and is supported by the required documentation.
Disposable goggles, for example, are said to be sterile on delivery, but the manufacturers of these goggles must also be able to provide documented evidence that the goggles have been packaged and sealed in aseptic conditions to comply with the regulatory requirements of the authorities.
As a specialist cleanroom service supplier for garments and goggles, Berendsen says manual cleaning or disinfection processes with wipes, baths or sprays are problematic because they give inconsistent cleaning results.
Varying vigilance and attention to detail by the individuals carrying out the manual cleaning process mean that any goggle can potentially become a contamination source if cfus and particles are not correctly removed every time.
Goggles processed by a qualified automated cleaning system and steam sterilisation or gamma irradiation provide documented evidence for a log 6 reduction, thereby minimising the risk of contamination.
A. After manual cleaning some fluorescent spray solution remains
B. After automated cleaning all the fluorescent spray solution has been removed
A comparison test was conducted by spraying a fluorescent solution on a batch of goggles prior to manual cleaning and on a second batch of goggles prior to the automated cleaning process.
Photos A and B show the results of the comparison test using a fluorescent spray solution on a batch of goggles prior to manual cleaning (A) and on a second batch of goggles prior to the automated cleaning process (B).
The results clearly showed the effectiveness and consistency of the automated cleaning process in removing all fluorescent solution, whereas after the manual cleaning the goggles had areas where the contamination by the fluorescent solution remained.
Berendsen research reveals that the lowest contamination risk derives from a reusable goggle designed to be processed following an automated cleaning and disinfection process and where all relevant traceable information is documented.
‘We have developed and qualified a cleaning and disinfection process where each goggle is always consistently processed, packed and sealed in a cleanroom environment,’ says Marco Bult, QA Manager Berendsen.
Berendsen has implemented radio-frequency identification (RFID) in its products so that it can ensure full traceability and can document, for example, that each goggle has been through its qualified cleaning and disinfection process.’
As the regulatory authorities increase standards, manufacturers need to ensure that they adhere to the recommendations being set. Previously simple tasks, such as picking a goggle for a cleanroom, now requires understanding as to whether use of direct or indirect ventilation holes is allowed, whether the goggles should be made from anti-fog glass for safety reasons, the use of rubber or fabric headbands, and much more.
Cleanroom operators need to consider whether they want to maintain and pay for their own storage facility, or save that cost and use a just-in-time service.
While contamination control specialists maintain that regulatory requirements are getting increasingly strict, companies can future-proof their contamination control set-up by looking only for solutions that allow all goggles in the cleanroom to be traced, and choosing a service that can document whether they have been processed according to the demands.
In summary, to meet the regulatory standards and increased focus on goggles as a source of contamination, companies with cleanroom environments should review their current standard operating procedures related to goggles; they have to provide documented evidence proving that the procedure meets the standards of organisations such as the FDA.
Berendsen can ensure that the reused goggles are effectively and reproducibly cleaned and disinfected and packed under qualified cleanroom conditions, supported by documented evidence showing compliance with regulatory and industrial standards.