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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
Grand River Aseptic Manufacturing (GRAM) is a clinical and commercial sterile manufacturing contractor to the pharmaceutical industry. It has lyophilization , terminal sterilization, analytical, microbiological testing services.
Sterling Industries is medical device contract manufacturer with manufacturing facilities and distribution channels in the U.S., Canada and Europe. [1] The company, established in 1984, specializes in the manufacturing and assembly of medical devices and sub-components.
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
Mark Wahlberg’s teenage daughter introduced the newest member of the famous family over the weekend.. Grace Wahlberg took to Instagram on Saturday, Feb. 1, to welcome an attention-grabbing ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
From clearing clutter to tackling key areas, learn how to strike the perfect balance between being prepared and letting the professionals handle the rest.