Pharmaceutical Technology-10-01-2004

This paper discusses the most important factors that a filter user must take into account when making a filter selection.

This article discusses the basics of sterile filter qualification and validation, with emphasis on bacterial challenge protocol development and testing. Reference is made to Technical Report no. 26 of the Parenteral Drug Association.

Steaming-in-place (SIP) is a widely adopted method for the in-line sterilization of processing equipment. The main advantage of SIP relies on manipulation reduction and aseptic connections that might compromise the integrity of the downstream equipment.

Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.

This article critiques the diffusive-airflow and bubble-point tests for their comparative suitability for integrity testing in pharmaceutical processes.