This Plant is dedicated B-Lactum facility manufacturing only Penicillin Anti-Biotic. B-lactum Facility is certified by WHO-GMP ( Food & Drug Control Administration Gujart State, Gandhinagar, INDIA. It is well designed with unidirectional flow of the material movement as well as the personnel movement. It is having a separate Air handling system to avoid the cross contamination and to achieve the desired environmental conditions for penicillin group of products. The store area is about 8410 sq. ft. The processing area & store area of B-lactum Unit is in the ratio of 40:60.
All critical processing areas in B-lactum Unit like Dry mixing, Tablet Compression, Capsule filling, sealing, polishing, blister packing, strip packing, bulk capsule filling where the product is exposed to atmosphere are designed for class 100000 condition. Ancillary areas such as quarantine, passages I, II, III, IV have 3-micron filters and passage V have 5-micron air filtration.
All production areas are kept under negative pressure compared to adjacent areas. All critical areas where the product is exposed to the atmospheric temperature is kept at 24+2°C and Relative Humidity is not more than 45%. To maintain the RH, finned strip heaters have been provided in the duct bank.