There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary. A broad issue for single-use filter users ...

The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent ...

Today’s market demand on biologic and pharmaceutical manufacturers to develop new drugs - combined with the economic environment - is challenging bio-processors to review their processing systems and ...

At different stages of the drug lifecycle, the minimum provision for parenteral products is a safety barrier against potential contaminants. This protection is guaranteed by selected container closure ...