7 Factors That Determine Appropriate Product Sterilization
Medical Product Sterilization Services
Medical product sterilization services are centered around creating sterilization validations for sterilization processes. There are seven primary methods for medical device sterilization. These methods are steam sterilization, radiation sterilization, dry heat sterilization, sterilization by filtration, gas sterilization (such as ethylene oxide sterilization), vapor sterilization, and liquid sterilization. You can read our article on which is the best sterilization method to learn which sterilization technique is best for your product. When it comes to medical product sterilization services everything from raw materials bioburden to packaging material selection to product storage impacts the sterilization and sterility of your products. The following article outlines top factors that influence medical product sterilization and medical product sterilization services that you might not know about.
#1: Microbiological Status Of Incoming Raw Materials Or Components For Medical Product Sterilization
Have a system for determining soil level (including bioburden) of the devices to be reprocessed. High soil level equipment (devices exposed to patient fecal matter or blood) should be subjected to a more thorough decontamination process than other devices.
#2: Validation & Routine Control Of Product Cleaning & Disinfection Procedures
In general, decontamination procedures in health care facilities consist of the following 7 steps:
- Precleaning -wipe and/or rinse, possibly presoak, and other preparations at the point of use
- Transport -move devices to the decontamination area;
- Disassembly -disassemble device as indicated and sorting parts accordingly
- Cleaning -remove bulk particulate and scrubbing any lumens or areas with high microbial accumulation
- Rinsing -wash away particulate from the cleaning process with appropriate water quality or specialty rise agents
- Microbicidal process -apply when necessary, to render items safe for handling
- Decontamination process verification -test periodically to make sure decontamination process results in cleanliness required for sterilization process or next use
Note: not all cleaning and decontamination procedures are appropriate for all types of instruments and devices.
#3: Control Of The Product Environment For Manufacture, Assembly & Packaging
After device manufacture, assembly for medical-grade products requires an ISO class 5 cleanroom. These class 5 cleanrooms are required to limit particles per cubic foot of air to prevent outside contaminants from compromising product sanitation. Packaging for assembled devices must also follow strict protocols and provide for appropriate sanitation following complete packaging of assembled devices.
Make sure that the manufacturing, assembly, and packaging environment for your product meet the needs for your terminal sanitation process requirements.
#4: Process & Equipment Control For Medical Product Sterilization
The following are 10 questions to ask yourself when evaluating process and equipment control for medical product sterilization of your device.
- Have you established Corrective Action & Preventive Action (CAPA) indicators of process problems?
- If CAPAs are established, did quality alone make the determination as to which CAPA was required or did you use a cross-functional department approach to CAPA selection?
Generally speaking, quality does not have visibility into all sources of internal data and information necessary to make the best possible decisions. Thus, a cross-functional departmental approach to CAPA is recommended.
- Are you using the process in question for manufacturing higher risk devices?
- Have you determined the degree of risk of the process causing any device failures?
- Are health care facilities familiar and experienced with the process recommended?
- Have you used the process to manufacture, sterilize, and/or reprocess multiple devices?
- Have you considered environmental and contamination control measures?
- Have you reviewed the device history records for operating parameters tolerance and handling of nonconformances?
- Have you reviewed the equipment for adjustment, calibration and maintenance? Has the process software (if any) been validated?
- Have you verified that personnel have been appropriately trained and are qualified to implement processes?
#5: Control Of Personnel & Their Hygiene
The following 4 steps are recommended to support with personnel hygiene:
- Implement a hygiene policy– Provide staff with a written hygiene policy that informs them of cleanliness intentions and expectations both in the workplace and when reprocessing reusable devices.
- Provide a clean bathroom– Make sure that the bathroom is well stocked with soap, toilet paper and hand towels.
- Provide clean wipes, sanitizer, masks and tissues- Provide items such as these in common areas and at medical device reprocessing stations to maintain a clean and hygienic workspace. Staff are more likely to use sanitation items if they are readily available.
- Implement regular cleaning- Make sure surfaces in sanitary storage and device reprocessing areas are wiped down regularly. In addition to reducing infection risk, a cleaned workplace also maintains morale and a sense of professionalism.
#6: Product Packaging Manner & Materials
Product packaging must have appropriate preformed sterile barrier systems or materials to protect devices from contamination while in storage.
Materials (such as wrapping materials, plastic film, papers, nonwoven fabrics or reusable fabrics) should meet the 8 general performance requirements detailed below:
- Materials must be non-leaching and odorless, such that neither performance nor safety of the materials are impaired and the medical devices they contain are not adversely affected.
- Materials must be free of holes, cracks, tears, creases or localized thickening and/or thinning that would impair their function.
- Materials must have a consistent basis weight (mass per unit area) according to their specifications.
- Materials must have appropriate levels of cleanliness, particulate matter, and linting.
- Materials must meet established specific or minimum mechanical properties (such as tensile strength, thickness variation, tear resistance, air permeance and burst strength).
- Materials must meet established specific chemical properties (such as pH value, chloride, and sulfate content) to meet the requirements of the medical device, packaging system and sterilization process.
- Materials must NOT contain (or release) substances known to be toxic in sufficient quantity to cause a health hazard either before, during or after sterilization.
- Materials must meet acceptance criteria for microbial barrier properties, unless they meet certain criterion of impermeability.
#7: Product Storage Conditions
Temperature, humidity, light exposure, ventilation, and air quality all play a role in the storage of medical devices. It is generally recommended to store products at a temperature range of 16–25°C and a relative humidity range of 30–75%. Avoid storing products in direct sunlight to avoid UV exposure and temperature increases. It is recommended to store your products in a well-ventilated area free from mold, smoke, dust, or salt exposure.
Ethide Labs is a contract testing organization that specializes in Sterilization Validations and EO Residual Testing. Ethide Labs provides in-vitro cytotoxicity tests in-house and outsources in-vivo cytotoxicity work for toxicity testing of medical devices, products, and drugs. Ethide Labs also offers Microbiology Testing, Bioburden Testing, Environmental Monitoring, Bacterial Endotoxin Testing, Package Integrity Testing & Cytotoxicity Testing services for medical device companies and allied industries. Ethide is an ISO 13485 certified facility.
References
International Organization for Standardization. Sterilization of heath care products- Moist heat – Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Geneva (Switzerland): ISO; 2006. (ISO 17665-1:2006 (R)2016).
McAuley, Terry et al. Specifications for temperature and humidity in sterile storage environments – Where’s the evidence? Healthcare infection. Volume 14, Issue 4, December 2009, Pages 131-137.
Chobin, Nancy. Maintaining Proper Sterile Storage Conditions. Infection Control Today. April 2018.
Spee, Jon. The 5 Most Common Problems With Your CAPA Process. Med Device Online. November 2017.
