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Comprehensive sterilization system design

When it comes to comprehensive sterilization system design, we thought of the design qualification first. Design Qualification means that autoclave manufacturer provides documented verification that the proposed design is suitable for the intended purpose and conforms to the user, functional, and regulatory and requirements. The conduct of a formalized design qualification for new facilities and systems is becoming increasingly commonplace in the global health industry. The execution of a design qualification for a steam sterilizer is certainly possible. However as the design expertise ordinarily lies with the autoclave manufacturer. The benefits of a formalized design qualification effort may be somewhat limited. Aspects of design qualification that might be more useful would be critical review of the vendor’s design compared with user requirements.
The design of a moist heat autoclave system should consider the requirements of the end user and lead to the creation of a User Requirement Specification. The User Requirement Specification means that a description of features and performance requirements of a system that will fulfill the needs of the end user. It is the responsibility of the end user to define the process outputs relevant to the intended operation of the autoclave. Features and functions which the end user deem important should be specified. Any specification that may impact the process output and product quality should be approved by the Quality Unit.

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The Functional Specification means that a description of functional attributes and operational characteristics of the system that will ensure fulfillment of the user requirements, also called functional requirement specification. Specifications what have said above are used to develop a Functional Requirement Specification, show how to achieve the User Requirement Specification and is normally provided by the intended vendors. Functional requirements may then be translated into a detailed design specification which may be produced by a collaborative effort between the vendor and customer. The detailed design stage produces the document for construction bidding and contracting, system and equipment purchase, fabrication, installation and testing.
Process knowledge determines the type of moist heat cycle that will best support the product. Influencing factors such as product type, process type, packaging and preparation should be considered in a risk assessment. For example, the configuration and packaging requirements of certain products is essential for the removal of air and penetration of moist steam heat. Other products and components may require an air over pressure cycle to effectively sterilize a contained liquid. Historical data is also useful in the design of a process, yet new processes may need to be developed to achieve the desired conditions. Risk assessment is a critical part of the moist heat sterilizer system design process. The assessment should consider the product and process flow first. Additional items that should be considered during a risk assessment include sterilization temperature, the loss of utilities, the loss of sterilization data, cooling requirements, steam requirements, air over-pressure requirements, critical instrument requirements, drain water level and door gaskets longevity and type and so on.

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