Stancold offers a cleanroom solution for the packaging of medical and healthcare supplies where specific standards must be met to ensure the safety of patients and industry standards.
Assembly and packing of medicines and devices used by the healthcare industry must take place in an environment that is to the correct GMP standards and is therefore free from contamination from outside sources. This includes printing, cartoning, testing and labelling of core pharmaceutical supplies.
Not only is the requirement necessary to ensure that the product is safe for patients, any medical or healthcare products also have to meet requirements that are set out by the pharmaceutical industry in the UK, as well as health organisations worldwide.
Stancold recommends that a cleanroom designed and installed for contract packing for the medical or healthcare industry meets ISO 7 standards as a minimum. Conditions include 60-90 air changes per hour and a maximum of 352,000 PPC (particles per cubic meter) at 0.5μm.
The walls of the cleanroom need to have a hygienic, non-particle shedding finish that is resistant to microbial and fungal growth. They also need to allow for a high rate of cleanability. We can offer advice on the best option for you, depending on your exact requirements, as all of our cleanrooms are custom-fitted to your site and product.
We have installed a range of ISO 7 cleanrooms that meet these standards for production and manufacturing and have years of experience working with the medical and pharmaceutical industry, including creating a cleanroom for GSK’s new Oral Solid Dose Production in Hertfordshire.
Our expert team can create a solution for any of contract packaging requirements that include anterooms for staff and the appropriate doors for access, as well as windows and other ancillaries. Whether you simply need a cleanroom for packaging, or for the entire process, including assembly and storage, we can help.
If you want to find out more about our cleanroom installation options for contract packaging, don’t hesitate to give us a ring on 07585 301 425 or drop Mark an email.
