Tag: cleanroom
-
Can gamma-proof data stem the tide of aseptic manufacturing deficiencies?
In news that’s starting to sound like a broken vinyl record, instances of voluntary recall and FDA warnings continue to plague the aseptic manufacturing industry. To wit: Baxter issued a voluntary recall for more than 427,000 units of sodium chloride injection and 54,528 containers of dextrose injection, citing “a lack of assurance of sterility” as…
-
“Lack of sterility assurance” in CGMP strikes again: Hospira issues a recall
We learned late last week that Pfizer subsidiary Hospira issued a nationwide recall of its vials used to inject sodium bicarbonate, citing sterility concerns. Not only will this cause undue financial damage to the company, but more critically it removes a volume of potentially lifesaving drug from the market. There’s a downstream impact, as well.…
-
Cleanroom Technology – Tego unveils touchless EM tracking for cGMP
“Tego’s solution includes TegoChip, which survives gamma sterilization, reduces risk of contamination and streamlines compliance processes for cGMP pharmaceutical facilities.” Cleanroom Technology magazine spotlights Tego’s ability to enable digital data on critical gamma and eBeam-sterilized components used during aseptic (sterile) manufacturing, to solve for visibility and traceability mandates in FDA-regulated cGMP manufacturing environments. Tego continues…