ALSHIFA manufacturing areas are designed to comply with clean room class 100,000 requirements that is a controlled environment where products are manufactured. Production rooms in which the concentration of airborne particles is controlled to specified limits. Eliminating sub-micron airborne contamination which is really a process of control. These contaminants are generated by people, process, facilities and equipment. They are continually removed from the air. The level to which these particles need to be removed depends upon the standards required. The most frequently used standard is the ISO 14644/BS 5295/ GMP EU classification. Strict rules and procedures for hygiene controls are followed to prevent contamination of the product. Clean room validation is carried out by third party to comply to with ISO and GMP regulations.
Strict Hygiene controls methods and employed for cleaning of the manufacturing areas and equipment. Special emphases are given to personnel hygiene control by training the workers for good hygiene practices in wearing antistatic dresses. Proper entry procedures into the clean areas, hand disinfection and wearing hand gloves during their presence in the production areas.