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.
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