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 two ways: Insufficient energy delivered to the load to sterilize. “wet packs”, making […]
In 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 steam is defined as a general purpose steam whose quality is not been […]
CAPA (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 document states e. g. that a pharmaceutical company should have a system in place […]
Technology 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 validation plans for facility / equipments / process including cleaning. Approval of protocols […]
