I’m looking to benchmark what area classification companies apply when dispensing raw materials for compounding activities when the material will go on to be filter sterilised and aseptically filled…Grade C or D?
Though there is no clear mention in Sept 2004 guidance from USFDA regarding area classification requirement for dispensing, this activity is also not mentioned in example given in EU Annex-1 for area classification wrt nature of activity to be carrired out, we we can rate this activity after ‘preparation of solution to be filtered’ on scale of area cleanliness/criticality. Dispensing is normally done under LAF/RLAF placed in grade D environment as industry practice.
EU_gmp_annex1.pdf (123.1 KB)
The dispensing booth is specially designed with recirculatory airflow system with high quality filtration provides a Class 100 clean environment and guarantees operator protection while
eliminating problems of cross contamination.
The standard dispensing booth is in a modular form which allows for rapid installation and integration into an existing facility. Generally they are constructed in single skin 304 quality 240 grit stainless steel, with external infill wall panels of epoxy coated mild steel. The ceiling plenum and associated housings in the technical area are also epoxy coated.
Based on OEL they should prevent
Air Borne cross contamination
Structural cross contamination
Operator borne cross contamination.
Based on the product that is dispensed and OEL the dispensing booth designs will change. For example if any one is using Immunosuppressants or hormonal products the OEL is 1microgram per meter cube: in such a situation they must have a Alpha/Beta port transfers with Drum or cassette.
At all times regulations under the Health and Safety Executive, MHRA and FDA (if applicable) must be strictly followed. In addition all rules pertaining to Good Manufacturing Practice (GMP) must be obeyed. Standard operating procedures (SOPs) are subject to the ‘validation procedure’ and all documentation relating to this must be kept secure.
Regards