Process Architrends

Suitable gowning in pharmaceutical facilities act as a shield protecting both product and person. Operator being a source of contamination should be covered suitably and also should be protected properly for exposure against potent and toxic products. Generally, gowning approach is directly or indirectly related to the product and process requirements. More Personnel Protective Equipment (PPE) are required as a part of gowning, while operating in a High Potent Oral Solid Dosage (HPOSD) facility. Whereas, sterilized wear is a requirement for aseptic manufacturing areas. Gowning is performed in  separate rooms or airlocks adjacent to operation area, where   personnel put on protective clothing after leaving the first area and before entering the second area. These airlocks can be more than one depending on procedural and HVAC requirements. The de-gowning operation should not violate the cross contamination control condition achieved in common areas. Procedures also should address e