The concept of upper and lower statistical confidence limits has been introduced to the
current media fill tests used for the assurance of aseptic operation. Results of media fill tests …

It is obvious that, in the media fill test and process simulation test, positive numbers in total
fills should not have any significant difference from zero or asepsis. There are many reports …

Aseptic filling is an aseptic process that requires the close coordination and complex
interaction between personnel, sterilized product, the fill/finish equipment system, clean …

Sterility testing and media fills are essential requirements in the pharmaceutical industry.
With the results obtained the manufacturer must ensure that the aseptic filling process is …

Background: Microbial contamination of compounded medications is a serious concern
within hospital pharmacies as it can lead to severe patient injury. The United States …

The validation of the aseptic process is particularly challenging. What are the principles and
methods for planning and designing the validation of sterile parenteral solution …

Due to inherently greater risks of nonsterility, aseptic processes are considered inferior to
terminal sterilization processes from a Sterility Assurance perspective. However, post …

Aseptic processing is a widely used technology in the field of pharmaceutical, biotech, and
medical device industries for the preparation of sterile materials. The term aseptic …

External and internal differences in pressure of prefilled syringes can cause plunger
movement during sterilization, which might cause drug product contamination …

The authors compare four well-established aseptic filling technologies, open vial, ampul,
blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology …