Steam Dryness: The measure of the water content of steam deliverd to the sterilizer chamber.Acceptable values are 0.9 or greater (<10% water) for non-metallic loads and 0.95 or greater (<5% water) for metallic loads. Wet steam can cause an unsterile load in…
read moreIn the pharmaceutical manufacturing and health-care industries, there are basically two types of steam–process steam and pure steam. Process steam is also known as plant steam, black steam, utility steam, boiler steam etc. Pure steam is sometimes known as clean steam. Process…
read moreCAPA (Corrective Action Preventive Action) and failure investigation become more and more important for the pharmaceutical industry. This becomes clear in a series of guidance documents. Above all with the ICH Q10 document, CAPA was introduced as a new quality-assuring tool. This…
read moreTechnology Transfer : Receipt of product design documents from Research Center. Distribution of documents received from Research Center (RC). Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record. Scale-up and validation of product Validation : Preparation of…
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