Tag: <span>disposable sampling</span>

One of the fundamental foundations of bioprocess system design is the use of “closed” systems for production. Closed systems and equipment are utilized to prevent contamination of the product. They are also used as a means of containment to protect not only the product, but also workers and the facility environment. The concept of a closed processing system makes common sense. What is surprising is how closed systems are defined and referenced within the body of regulatory guidance documents and how companies differ in their implementation of a “closed manufacturing” concept. What is not surprising is the impact that closed systems have on facility design…

Manufacturing Risk Analysis and Management