Aseptic Technique

Aseptic Technique various option.

Aseptic Technique

Aseptic Process

Various sterile Technique adopted for aseptic handling

Manufacture of sterile active pharmaceutical ingredients

Closed system
A closed system is sterilised-in-place or sterilised while closed prior to use, and is pressure
and/or vacuum tight to some predefined leak rate. Such a system can be utilised for its
intended purpose without breech to the integrity of the system, can be adapted for fluid
transfers in and/or out while maintaining asepsis, and is connectable to other closed systems
without loss of integrity.

Manufacture of sterile active pharmaceutical ingredients

Aseptic processing

Handling sterile materials in a controlled environment, in which the air supplies, materials,
equipment and personnel are regulated to control microbial and particulate contamination to
acceptable levels.

Manufacture of sterile active pharmaceutical ingredients

Active Pharmaceutical Ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture of a drug
(medicinal) product and that when used in the production of a drug becomes an active
ingredient of the drug product. Such substances are intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of
disease or to effect the structure and function of the body
Note: Active pharmaceutical ingredients are usually first obtained in the crude state.
Subsequent production operations convert the crude material to the final API that meets the
pharmacopoeial and/or similar requirements.
A sterile API is an API that has been subjected to additional processing steps to remove microorganisms,
particles and/or endotoxins.

Manufacture of sterile active pharmaceutical ingredients

Active Pharmaceutical Ingredients (API’s), used as ingredients in sterile medicinal products,
must be sterile unless the final dosage form is terminally sterilised, or produced by a process
including a sterilising filtration step. API’s intended for use in parenteral products must also
comply with relevant specifications on pyrogens or bacterial endotoxins.
The manufacture of sterile API’s must be strictly controlled in order to minimise the risk of
contamination with micro-organisms, endotoxins and particles. If the final dosage form is not
to be sterilised by filtration, the API’s should be practically free of particles.