![]() ![]() After a certain operating time of the filter and depending on the ambient parameters (temperature, humidity), the sealing compound with which the filter package is sealed into the frame can become "brittle" and air-permeable.Is there a risk of filter damage when manipulating in the tool area (tool exchange, cleaning, etc.)? If this can be the case, a leakage test would be advisable according to the risk assessment. A leak in a HEPA filter does not occur by itself, but mostly due to mechanical stress/damage when handling the filter during installation (detected during acceptance measurement = function test).Studies have shown that in the event of a leak, approximately 3% of the particles upstream of the HEPA filter can penetrate through the leak.) What is the contamination of the air immediately upstream of the HEPA filter during normal operation? Are pre-filters used, if so, what is the separation efficiency of these filters? (Used to assess what effect a leak in the HEPA filter can have.what is the risk for the person using this product in case of potential contamination due to a leak in the HEPA filter? (In the extreme case, the result would be: No cleanliness class ISO 5 is required - this makes the other points obsolete!) Most important: What effect does a potential leak in the filter have on my product? I.e.In a risk assessment for the evaluation of a leak in a HEPA filter (class H13 or H14 according to EN 1822), the following points would have to be considered (no claim to completeness): ![]() a purely "commercial" operating permit is in place, one can only use the ISO guidelines as a basis for assessment.Īll guidelines have one thing in common when setting an inspection interval: the risk should be assessed. This means: If the approval was granted under the EU GMP Guide, one should use the "requirements“ of the GMP Guide in addition to the ISO 14644 series for the assessment. The GMP guidelines in turn refer to the ISO 14644 series of standards for cleanroom-related topics. In addition, the EU GMP Guide, whereby "aseptic" production can be excluded, can form the basis of the approval, whereby "non-sterile production" also does not specify Grade A (ISO 5) or B. Since an injection moulding machine is involved, the Medical Devices Directive may also be authoritative, depending on the product manufactured and its use (e.g. Although the GMP guidelines are legally considered a "recommendation", the recommendations of the guidelines are considered a "requirement" by the authorities/inspectors and are also evaluated as such. If the facilities and the production operations are approved and conducted in accordance with GMP, the legal requirements still provide the primary governance. The legal requirements according to which the permit was issued should also be apparent there. What points should the risk assessment cover?Ī reference to the periodic review could be included in the operating permit. When particle contamination due to airborne contamination is detected on the product.When the life expectancy specified by the manufacturer is reached under the given operating conditions, the interval should be reduced to annually or semi-annually (result of the risk assessment).Recurring inspection for new filters after one year, thereafter after 3 years, if no other event as per EN ISO 14644-3, Annex A.3, a) to d) occurs beforehand (see section "Which GMP regulations and standards apply here?").During initial installation or replacement of the filter.Recommended test interval for HEPA filter integrity testing In the revision of Annex 1 (draft 2020), these intervals are already described (see under "Which GMP regulations and standards apply here?"). On the part of the authorities, however, a semi-annual inspection is expected for ISO class 5 (laminar flow is equated with GMP Grade A). How often should the terminal HEPA filter integrity test be performed? Is there a default? Or do we need to perform a risk analysis and determine the intervals based on this?Ī) If the (commercial) operating license was granted according to purely legal requirements, a documented risk assessment is recommended in any case to justify the inspection intervals.ī) If, in addition to the legal requirements, the operating license is also in accordance with EU GMP guidelines, it is sufficient, until the revision of Annex 1, to carry out a documented risk assessment to justify the test intervals (see under "What points should the risk assessment cover? "). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |