Product Application in Medical Pharmacy

MEDICAL PHARMACY

KLC & Pharmaceutical Industry

In the field of bio-pharmaceutical, the air cleanliness requirements of the production workshop are extremely demanding. The dust particles attached with microorganisms could be carried by the personnel and materials into the production area, which will highly increase the potential risk of contamination, causing safety issues such as drug deterioration and pollution.

For this reason, if the air cleanliness in the production area is not up to standard, it will directly affect the quality of the finished products. Therefore, building a production workshop that fully complies with GMP standards is the top priority to ensure the safe production of pharmaceutical products.

As a clean air solution expert, KLC is professional in providing customers with safe, effective, energy-saving and environmental friendly pharmaceutical clean air solutions and products. We combine the latest version of the GMP specification, aimed at the requirements for airborne particles, temperature and humidity in the production areas of A, B, C, D different cleanliness grade to create a clean production workshop fully meets the high standards of GMP.

The clean room area is divided into four grades:

Grade A area, High risk operation area, the area that directly affects the operation, such as tunnel sterilization oven, aseptic filling, bottle opening, autoclave sterilization cooling zone, etc. In this area, the air cleanliness requires 100-level laminar flow, areas directly affect product quality and are defined as grade A.

Grade B area, Area which indirectly affects the aseptic operation area and directly surrounding the grade A area, such as aseptic filling room, autoclave cooling room.

Grade C and D area, The transitional clean area that enters the aseptic production area, such as preparation room, dressing room and buffer room.