The “at rest” state is the condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.
The “in operation” state is the condition where the installation is functioning in the defined operating mode and the specified number of personnel is present. The areas and their associated environmental control systems shall be designed to achieve both the “at rest” and “in operation” states.
Validation of the AHU HVAC system shall be done in both at rest and in operation conditions. Validation of aseptic processing shall include a process simulation test using a nutrient medium (media fill).
Selection of the nutrient medium shall be based on dosage form of the product and selectivity, clarity, concentration and suitability for sterilisation of the nutrient medium.
Our company Pharmadocx Consultant helps in establishing pharmaceutical plants, GMP Certification and also obtaining Drugs manufacturing license like Form 25, Form 28 etc.
Pharmadocx FDA Consultant
Sonipat Office -
Opposite Dewan Mill, Old DC Road, Sonipat-131001
M:- 9896133556
Delhi Office -
G-12, Pearls Best Heights-1, Netaji Subhash Place, Delhi-110034
Ph:- M:-8708385761