Biopharma and vaccine manufacturing company Cellon’s entire range of PharmaTainer bottles and carboys are now certified ‘clean,’ and meet USP 788 Particulate Matter in Injections as well as the equivalent EP and JP quality standards.
According to the Luxembourg-based company, the products are currently manufactured in PC and PET in sizes from 125ml to 20l in an ISO class 5 environment and sterilized by irradiation to a SAL of 10-6.
PharmaTainer products provide tamper evident packaging and have been designed for the storage and transport of bulk vaccines, biopharmaceuticals, bulk intermediates and other biotech materials specifically.
Cellon managing director Richard Fry said the range addresses the primary quality concerns for single-use storage and transport containers in the industry.
"We reduce risk by manufacturing for a single purpose and quality standard. So, there is less opportunity for error in our operations than in multipurpose moulding facilities that manufacture products of differing levels of cleanliness using multiple grades of materials," Fry said.
In 2011, Cellon opened its production molding facility in Luxembourg, which produces clean, single- use products for use in the vaccine and bio-processing sector.