News in Brief
PRIMUS to distribute Astell products in North America
The US manufacturer of steam sterilizers offers autoclaves from benchtops to bulks.
PRIMUS said the partnership allows it to continue to support the life sciences market.
Jim Fry, PRIMUS president and CEO, welcomed the venture.
“The addition of the Astell range of products provides the PRIMUS distribution channel a complete range of products from Benchtop through Bulk Autoclaves. The creation of a national US service center will offer customers a centrally located base of support for all Astell products.”
Astell Scientific is a UK manufacturer of autoclaves/sterilizers, steam generators and Effluent Decontamination systems (EDS) and its products are used in more than 100 countries.
“Astell and Primus have worked together for some time now and both agree that the Astell circular section range provides the perfect match to complement Primus’s existing range of square section sterilizers,” said David Pennock, president of Astell.
Astell autoclave controller software
Meanwhile, Astell has launched a new software option that enables its autoclaves to meet FDA 21 CFR Part 11 electronic signature regulations.
It is targeted towards customers in the pharmaceutical and medical manufacturing industries but can bring benefits to other applications should traceability be of importance when specifying a sterilizer.
The Electronic Records; Electronic Signature final rule (21 CFR 11) legislation ensures any computerized system used for regulatory purposes produces electronic records that have integrity and reliability and electronic signatures are trustworthy and equivalent to handwritten signatures on paper records.
Available for circular and square section sterilizers, the controller software captures changes made to a cycle, option, or device parameter – which will require an electronic signature authorisation.
All device changes and signatures will be electronically logged and can be recalled to provide a picture of user input for a point in time. All audit trails are saved in a file format that cannot be altered.
