Frequently Asked Questions
What is meant by aseptic?
Aseptic is the absence of microorganisms capable of causing infection or contamination.
What is aseptic processing?
A method of producing a sterile (absence of living organisms) product in which sterile bulk drug or sterile raw materials are compounded and assembled with sterile packaging components.
What is the objective of aseptic processing?
The objective of aseptic processing methods is to assemble previously sterilized product, containers and closures within specially designed and controlled environments intended to minimize the potential of microbiological or particulate contamination.
What is a clean room?
A room or suite of rooms where sterile conditions are required. The rooms have a defined environmental control of particulate and microbial contamination and are constructed, maintained, and used in such a way as to minimize the introduction, generation, and retention of contaminants.
What is meant by cGMP?
cGMP is the acronym for Current Good Manufacturing Practices. cGMP is defined as a set of current, scientifically sound methods, practices or principles that are implemented and documented during product development and production to ensure consistent manufacture of safe, pure and potent products.
Why must manufacturers establish environmental controls?
Manufacturers must establish and maintain procedures to adequately control environmental conditions where they could reasonably be expected to have an adverse effect on product quality. Lighting, ventilation, temperature, humidity, air pressure, filtration, airborne contamination, and static electricity are among many conditions to be considered for control.