29 September - 1 October 2020
Prague, Czech Republic
Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. The question can be answered with a clear 'No'. There are approvals for pharmaceutical products only, not for production equipment. Authorities or GMP guidelines neither allow equipment, nor do they forbid their usage (with the exception of filters emitting fibers). Here, companies have the freedom of choice but also the responsibility to use the equipment appropriate for their process or product. Standard equipment can be modified to fit best on the own process.
GMP guidelines require that the selected equipment is suitable for the application and which can be sufficiently cleaned and maintained. Surfaces that have contact with in-process material or product are supposed to be non-reactive, additive, or absorptive to prevent that the quality decreases beneath the defined requirement.
With regard to lubricants and synthetic/sealing materials this is different. The US FDA does not admit any seals, but has a white list of substances in their guidelines text they consider harmless. However, this merely means that these substances are not toxic in small quantities and therefore may be used. It does not imply their suitability for the own process or the proof of compatibility. For instance, EPDM is listed as sealant in 21 CFR 177.2600, but is not resistant in contact with oils or fats and may not be used in these cases.
With regard to lubricants there is also a Positive list in the CFR, to which the components of a lubricant must be traceable. Alternatively, lubricants can be listed by the NSF in the so-called White Book. To do this, the NSF offers a registration procedure, which shows the toxicological safety.
In addition there are organisations that may be of benefit for the selection of equipment or equipment parts. For example, the EHEDG checks and certifies the cleanability of equipment. The Fraunhofer IPA rates materials with respect to their cleanroom suitability. Here, cleanability, organic resistance, abrasion / particle emission and outgassing are examined.