It is important to clean pharmaceutical equipment after manufacturing a product so that subsequent products are not contaminated. Removal of previous product residues from production equipment is known as cleaning. If the entire process of cleaning is documented, this is referred to as validation of ...

Protocol First, you need to create a protocol. When preparing a protocol, water quality, detergent used, rinse duration and system size should be considered. The protocol should contain the purpose of the entire process, scope of the protocol, responsibilities of departments, cleaning procedures, acceptance ...

The Food and Drug Administration states that cleaning equipment before use is nothing new, so the 1963 GMP regulation (Part 133.4) declares that “equipment shall be kept very clean and orderly.” A similar section for instrumentation cleansing (211.67) was included in the 1978 CGMP rule. Of ...

1. FDA expects firms to have written standard operating procedures (SOP) detailing the cleaning process used for various pieces of equipment. 2. If firms have a specific cleaning process for cleaning between different batches of the same product and use a different process for cleaning between product ...

In order to have efficient cleaning methods, the following strategy is required. The cleaning strategy of a diagnostic company should be to minimize the risk of product quality. Cleaning validation is directed towards situations or process steps where the potential for carry-over poses the greatest risk ...

Pharmaceutical products and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by micro-organisms or by other material (e.g. air-borne particles, dust, lubricants, raw materials, intermediates, auxiliaries). In many cases, the same ...