STERIS kuala ketil, malaysia x-ray operations recieve ISO 13485 accreditations

• Accreditation includes gamma, X-ray, and ethylene oxide processing
• Allows additional radiation processing capacity in Asia

July 2023 - Earlier this year, STERIS announced the addition of X-ray sterilization services at our existing Kuala Ketil, Malaysia gamma and ethylene oxide facility. As part of our long-term commitment to supporting global medical device manufacturing, STERIS is pleased to announce the Kuala Ketil facility has now received its updated ISO 13485 accreditation to include X-ray processing. To view a copy of our certificate, please go here.

The Kuala Ketil facility is the first X-ray processing location in the APAC region, providing additional radiation processing capacity for medical device and pharmaceutical manufacturers in the region. We are also adding X-ray processing capacity to our existing Chonburi I, Thailand gamma facility, which was previously announced in 2021.

In addition to the new X-ray facility in Kuala Ketil, we support medical device manufacturing in Malaysia through our existing ethylene oxide, electron beam, gamma, and microbiological testing services in Kulim, Port Klang, and Rawang. We also recently announced the addition of ethylene oxide processing through a new site being constructed in Batu Kawan, Malaysia.

Increased demand in medical device manufacturing has accelerated our plans for global expansion. The continued expansion of processing options throughout our global network allows us to support Customers with both routine services and processing redundancy.