Sterilisation Services

 

Sterilisation & Packaging Services


ETO Sterilisation

Using the latest ETO Sterilising facilities, provides the most cost effective way to sterilise large or small volumes of Medical Devices.

Heinrich & MDSS Ltd is a medical device specialist in Ethylene Oxide (ETO) Sterilisation. They provide regulatory compliant and cost effective ETO Sterilisation solutions for the healthcare industry.

 

Heinrich & MDSS operates in accordance to the Good Manufacturing Practices. Their ETO facilities are certified to international standards such as ISO 9001 and ISO 13485. Their ETO Sterilisation process is operated in accordance and compliance to ISO 11135:2014 and they are audited for “Provision of Ethylene Oxide Sterilisation Services of Medical Products in accordance with EN ISO 11135:2014”.

 

The treatment of medical devices by Ethylene Oxide (ETO) is the principal method of sterilisation in the healthcare industry. With technological advancements and the increasing regulatory demands, the requirements for a stable and compliant partner is critical.

The state-of-art ETO Sterilisation facility is used to sterilise medical and pharmaceutical products that cannot support conventional high temperature steam sterilisation – such as devices that incorporate electronic components, plastic packaging or plastic containers.

ETO gas infiltrates packages as well as products to kill micro-organisms that are left during production or during the packaging processes.
 

Cleanroom Services


The cleanroom services combine all the specialist skills and state-of-art technologies you’d expect from a team whose customers include market-leading companies with high expectations. The facility incorporates a cleanroom specified to operate at ISO Class 7 (10,000) level or higher. Within their cleanroom they have laminar flow booths for projects that demand even higher operating classifications, as well as separate zones for different types of work or product.

To help maintain the high standards and superb levels of consistency customers depend on, the in-house testing laboratory is where they carry out off-line product testing to include bioburden and sterility testing. All the facilities are fully certified and the company is accredited to ISO 13485:2016.
 

What we pack?


Heinrich & MDSS is completely customisable, you can use all or part of the service tailored to your specific needs. At the medical packaging facility, they can pack almost any type of medical device including Surgical Instruments, Orthopaedic Implants, Dressings, Screws, Drill bits, Burs, Swabs, Suction tubes, Forceps and Nippers. We can also assemble kits and procedure packs to your specification.

Sterilisation & Packing Facilities

For more details on this service, please contact our CUSTOMER SERVICE TEAM on 01527 559010, who would be happy to assist you.