In the field of immunology and vaccine development, adjuvants are vital components that enhance the immune response elicited by vaccines. One such adjuvant, QS-21, a natural product extracted from the bark of the soap bark tree (Quillaja saponaria), is an attractive candidate for use in vaccines.
Equipment that complies with good manufacturing practice (GMP) is essential for producing pharmaceutical products that are pure, safe and effective. The design, function, qualification and control of such equipment must meet high standards in the manufacture of these products.
It is well known that human intervention increases the risk of finished product sterility failure during the aseptic filling process. For traditional aseptic filling lines using RABS, human intervention is often required, such as adjusting conveyor belts, turntables, vibrating bowls, star wheels through gloves.
When it comes to the production of sterile products, EU GMP Annex 1 is the highest standard that pharmaceutical manufacturers must adhere to. To provide a Class A environment and ensure sterility, barrier technology (either isolators or RABS) is the best solution to address critical factors such as quality of air, material and ingredient transfer, decontamination, etc. mentioned in Annex 1.