In the "GMP" management of pharmaceutical and pharmaceutical industries, the requirements for sterilization and elimination of heat sources of drugs and drugs that are contacted with drugs will be higher and higher.
The company has accumulated the experience of designing and manufacturing various electric heating sterilizers for a long time, digested and absorbed the advantages of the foreign products of the same kind, and carefully designed and developed the GM100- series of dry heat sterilization (except heat source) box. The device conforms to the requirements of FDA, GMP and US federal standard 209E, and provides reliable help for GMP transformation and FDA verification in the domestic pharmaceutical industry.
Principles and characteristics
Electric energy can be used as heat source (dry heat), which can be sterilized at 250 C for a long time, providing a reliable guarantee for eliminating heat source.
The working temperature is programmed by computer or according to requirements. PLC computer control is used to automatically record two internal temperature.
A high efficiency filter is installed in the inlet and outlet to prevent internal pollution.
The internal circulation hot air is filtered by the high temperature and high efficiency air filter to ensure that the hot air entering the effective space reaches the 100 level clean requirement.
Double doors in two different clean areas are controlled by electrical or PLC computer control to ensure isolation between clean areas and prevent accidents that are not in line with GMP requirements due to misoperation.
The design of this device is in line with the 98 edition of our GMP code. All materials are made of imported stainless steel and welded by argon arc welding. There is no dead angle and no sharp angle in the interior. The surface of the outer wall is passivated into sub bright, and the inner surface of the wall is polished precisely.
There is a GMP verification interface on the device.