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GMP sterilizer

The term GMP sterilizer has no official definition, in other words, there is no specific requirements for pharmaceutical manufacturing. However, it is commonly understood that a GMP steam sterilizer is a unit designed for moist heat sterilization, and in accordance with current pharmaceutical industry sanitary design standards. Non-GMP sterilizers are uaually used for the sterilization of such items, including not used for processing product, product contact items, microbiological test items or items contacting primary product packaging and so on. These autoclaves may include some features of GMP sterilizers, but may not have the precise control or recording of temperature and pressure which GMP sterilizers need. Each type has their corresponding typical features.
For example, the typical applications of GMP sterilizers include sterilization of products used in the testing or manufacturing of drug products, and the terminal sterilization of liquid products in sealed containers. While the typical applications of Non-GMP include the sterilization of such products used for laboratory work or sterilization of waste materials prior to disposal. It is worth mentioning that not supporting a production area or product testing. In the GMP sterilizers, autoclave piping and autoclave chamber are desinged to accommodate clean utilities. Such as pure or clean steam as well as process air. This includes stainless steel clamped and welded designs, proper slopes and deadlegs. In the Non-GMP sterilizers, the autoclave piping and autoclave chamber are designed as appropriate for the intended use of autoclave, for example, the copper piping. In the GMP sterilizers, the materials of construction are compatible and appropriate, such as non-particle generating, with products and processes ensuring no contamination, such as product or environment. May be supported by certificates of inspectionn and traceability. While in the Non-GMP sterilizers, the materials of construction appropriate for the intended use of sterilizers, for example, ensure no adverse reaction with load items to be sterilized.
In the GMP sterilizers, product contact utilities such as water, steam and air supplied to the sterilizers are suitable for its intended use and meet applicable compendial expectations. In the Non-sterilizers, load contact utilities such as water, steam and air supplied to the sterilizer are suitable for its intended use. In the GMP sterilizers, the control and monitoring systems of data security and integrity meets regional regulatory expectations. Temperature monitoring and control devices such as drain probes are independent of one another. And performace meets the requirements and specifications of Quality Unit oversignt. In the Non-GMP sterilizers, the control and monitoring systems of data security and integrity meets the requirements of internal organization. Temperature monitoring and control may be from a single device. And the performace meets the requirements and specifications, but the Quality Unit oversight may be not required.

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