Sterilization Of Medical Devices
A sterile medical device is one that is free from viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device from all sources be minimized.
Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (for example, ISO 13485), prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. In healthcare industry, the purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.
WSSSB’s Certified Sterilization Service Centre (CSSC) in Kota Kinabalu Industrial Park (KKIP) play an important role in providing sterile products to the various end users in the healthcare industry in Sabah e.g. the operation theatres, emergency department, maternity, wards etc. through a series of strictly monitored cleaning, disinfecting, packing and sterilizing processes.
In current healthcare industry demands exacting sterilization standards and quality to meet the current business requirements. WHS Sterilization Service Sdn Bhd (WSSSB) delivers just that. We provide innovative sterilization processes at our sterilization facility in Kota Kinabalu Industrial Park (KKIP), Sepanggar, Sabah, at the highest standards compliance and the specialized expertise to ensure consistent results for our clients.
WSSSB provides 2 types of sterilization methods:
1. Steam Autoclave Sterilization
An autoclave is used to sterilize surgical equipment, laboratory instruments, pharmaceutical items, and other materials. It can sterilize solids, liquids, hollows, and instruments of various shapes and sizes by using the power of steam to kill bacteria, spores and germs resistant to boiling water and powerful detergents. An autoclave chamber sterilizes medical or laboratory instruments by heating them above boiling point.
In our Central Sterile Supply Centre (CSSC) in KKIP, we are using CISA brand steam autoclave with the modal of GLOBO P-640H and can process numerous surgical instruments in a single sterilization cycle, meeting the ongoing demand for sterile equipment in operating rooms and emergency wards.
The autoclave works with saturated steam as a sterilising agent with a wide temperature range up to 143 °C and pressure range up to 3.5 bar.
CISA GLOBO P-640H steam autoclave is designed to cover a vast range of applications: in hospitals, medical centres and pharmaceutical and biotechnology industries. These CISA devices are built in accordance with Standards: ISO 13445, UNI EN ISO 9606-1:2013, UNI EN ISO 15614-1, UNI EN 285, UNI EN ISO 17665-1, CEI EN 61010-1, EN 61010-2-040 and EN 60204-1.
2. Ethylene Oxide (ETO) Sterilization
Based on a gas diffusion process, ETO is capable of sterilizing and rendering products free of viable microorganisms. Sterility occurs when an ETO gas molecule reacts with and destroys the microbial DNA. The process requires the simultaneous control of four variable, but interdependent parameters: gas concentration, temperature, relative humidity and time of exposure. ETO effectiveness depends on its ability to freely diffuse through a product and packaging. All products must be placed in breathable packaging that allows gas to penetrate the sterile barrier and reach all surfaces of the device or product. The ETO type currently use for the sterilization operation in KKIP is 5XL Gas Sterilizer/Aerator.