Production facilities for parenetral products
The production of parenteral products requires special precautions and facilities in order to maintain sterility and freedom from any particulate matter. Hence the production area of parenteral products can be divided into main five sections:
- Clean up area
- Preparation area
- Aseptic area
- Quarantine area
- Finishing and packaging area
Clean up area:
It is not an aseptic area. The area and environment of the room should be free from dust, fibres and microorganisms. This area should be constructed in such a way that it can withstand moisture, steam and detergent. Ceiling and walls can be coated with epoxy resins to prevent the accumulation of dust and microorganisms. Exhaust fans should be fitted in this area. This area should be kept clean to eliminate the chances of entry of contamination into the aseptic area. The containers and closures are washed and cleaned in this area.
Various ingredients of the formulation are mixed and prepare for filling into the final container into this area. It is not essential that this area is aseptic. Cabins and counters should be made up of stainless steel and filled in such a way that no space is left for accumulation of dust. Ceiling, walls and floor should be properly cleaned and painted to eliminate the chances of contamination.
The parenetral formulation is filtered, filled into final container and sealed in this area. The air ij aseptic area should be free from any type of contamination, fibres or microorganisms which is
achieved by use of HEPA (High efficiency particulate air) filters which can remove 99.97% 0.5µm or larger particles from the air. HEPA filters are fitted into the laminar air flow system in which air free from dust and fibres move in uniform velocity. Ultra violet lamps are also fitted to maintain sterility. The entry of personnel in this area should be through air lock system. The trained personnel should only be allowed to enter in this area. The personnel entering in this area
should be neat, clean, reliable and wear sterile clothing. There should be minimum movement into this area. The environment of this area should be class 100 room (means less than 100 particles per cubic feet of 0.5µm or larger size should be present).
The preparations after filtering, filling into final container and sealing are kept in this area. Then random samples of preparations are sent to quality control department for evaluation. After passing the evaluation, the preparations are transferred to finishing and packaging area.
Finishing and packaging area:
The parenteral products are properly lebelled and packed in this area. Proper packaging is required to protect the product from physical damage during transportation, handling and storage. This area is not aseptic.