How are sterile products manufactured?
In general, there are two ways to manufacture a sterile drug product: Aseptic Manufacturing and Sterile Fill-Finish: A process in which the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together (aseptic manufacturing).
What is aseptic pharmaceutical manufacturing?
Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products (typically food or pharmaceutical) are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration.
What are the general considerations in WHO good manufacturing practices for sterile pharmaceutical products?
General considerations 1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials.
What is non sterile manufacturing?
Non-sterile compounding are medications made in a clean environment that’s not completely free from all microorganisms. This type of compounding is for drugs to be taken orally or topically.
What is sterile manufacturing unit?
It focuses on the final formulation, filling, and finishing (initial packaging) of injectable products. The term sterile manufacturing facility is used throughout this chapter as a description of a range of facilities that produce injectable products for humans.
What is the difference between sterile and non-sterile manufacturing?
Sterile compounding is used when there is a high risk of infection, such as drugs given as an injection, through an IV, or directly into the eyes. Non-sterile compounding medications include pills, liquids, gels, lotions, ointments, creams, shampoos, lip balms, and more.
What are the principles of good manufacturing practices?
The most compliant principles of GMP include (1) designing and constructing the facilities and equipment properly and identifying the responsibilities; (2) following written procedures and instructions; (3) documenting work; (4) validating the processes and evaluating the staff performances; (5) monitoring and regular …
How you can ensure that your manufactured pharmaceutical product is free from any microbial contamination?
Maintain aseptic process rooms at a high differential air pressure. Do not set ambient humidity or temperature at an uncomfortable levels. Based on product risk assessment / facility, use Restricted Access Barrier System, Isolators Systems, Ventilated Cabinets, etc. to help contain microorganisms.