PROCESS water chiller manufacturer Matsu Chilling Systems has announced its Therapeutic Goods Administration (TGA) compliance plan for chillers manufactured for pharmaceutical producers in Australia.
TGA requirements for pharmaceutical producers are extensive, and meeting documentation requirements for new capital equipment is often a time consuming and costly process.
Just complying with the Code of Good Manufacturing Practice can be a costly exercise.
In addition to the TGA requirements, many Australian subsidiaries of larger companies have adopted international standards that are applied world wide. These quality standards are often more rigorous than Australian TGA requirements, as these companies want to far exceed TGA requirements rather than just meet the minimum.
Matsu Chilling Systems, after extensive research and consultation with the TGA, is able to assist pharmaceutical manufacturing and packaging companies with compliance issues for chillers in Australia in two ways:
* Firstly, by manufacturing specifically to a quality standard relevant to pharmaceutical producers in Australia, every chiller is documented thoroughly with individual components certified where necessary. Replacement of components can be easily undertaken with all parts carried locally, keeping the validation process simple, or eliminating the need for re-validation altogether.
* Secondly, by offering a monitoring process on implementation of the chiller, Matsu Chilling Systems is able to assist with the validation process required from the Australian TGA. Chiller operation is certified to calibrated measuring equipment, far exceeding TGA requirements.
Matsu Chilling Systems general manager Daniel Rollston said there was no other chiller company in Australia who could do this.
"We are able to assist pharmaceutical manufacturing companies to reduce paperwork and reduce cost significantly,” he added.
Based in Sydney, Matsu Chilling Systems manufacture process water chillers for most industrial applications.