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Contract Sterilization - Medical Devices

Datwyler Study

ClorDiSys offers contract sterilization of your FDA regulated medical devices at our facility in Branchburg, NJ using chlorine dioxide (CD) gas. As an FDA approved Contract Sterilization Facility (Registration# 3013115071) using an EPA registered sterilant (Registration# 80802-1), our facility is perfectly suited to handle your sterilization needs. We have a complete, audited Quality System in place and a notice of pending ISO 13485 registration to further accommodate any medical device. Your product will be sterilized in a dedicated chamber using your unique, validated, custom cycle. This customer focused approach allows for custom procedures and work instructions when processing and handling your products. Upon completion, your FDA regulated medical devices can be either returned to your facility or drop-shipped directly to your customers.


ClorDiSys offers a very user-friendly service and can assist with both Cycle Development and Validation to help easily transition your sterilization over to chlorine dioxide gas. CD gas is very similar to ethylene oxide (EtO) in how it is utilized and the SAL sterilization levels that can be achieved. CD gas holds advantages in the types of devices that can be sterilized, the overall processing time, and its environmental impact. CD is not explosive or carcinogenic and leaves no harsh residues, allowing it to be used for the sterilization of items with embedded batteries. In almost all locations, it can simply be exhausted to the environment rather than needing to be scrubbed with hazardous solutions. It is non-flammable and non-explosive at use concentrations, so it does not require expensive damage limiting construction. An integrated UV-VIS spectrophotometer measures and controls the gas concentration throughout the sterilization cycle ensuring the success of every cycle and allowing for parametric release. CD gas requires much shorter overall cycle times, allowing for products to get to the customer much faster. Devices can be packaged in Tyvek® pouches, display boxes, or final shipping containers. CD gas is friendly to most materials and electronics, and ClorDiSys can assist with material compatibility testing to ensure your product is compatible. ClorDiSys has a draft Device Master Reference file available as a guide.


Device Master Record

Chlorine dioxide is the method usually recommended when devices have imbedded batteries which are not affected by CD. CD does not get absorbed into materials like EtO does, so an aeration time of under 30 minutes is typical. Chlorine dioxide is a true sterilant gas and works at ambient temperature. The boiling point of CD is low, at -40°C. CD gas will not condense on devices. It is a surface sterilant, therefore CD gas can sterilize prefilled syringes, while maintaining drug integrity, and medical devices with complex geometries.


Chlorine Dioxide Gas Molecule Size


Surgical Kit

The CD Gas Advantage

Chlorine dioxide gas sterilization is ideal for sensitive biotech products and improves supply chain efficiency:


  • ClorDiSys' CD Gas is an EPA registered sterilant, making it effective against all viruses, bacteria, fungi and spores

  • Non-carcinogenic, residue free process

  • Ambient temperature sterilization (0°C - 50°C) - can be customized for unique applications

  • Adjustable vacuum levels - can be customized for unique applications

  • Surface sterilization process - does not get absorbed in most materials for quicker aeration

  • Short cycle times - 2 to 8 hours including aeration

  • Safe and easy to bring in house - reduces manufacturing time and cost

Aerates Rapidly - Minutes vs. Days

Properties as a non-vapor, surface sterilant with a low boiling point, coupled with the low CD sterilant concentrations, translates into rapid aeration of the sterilization chamber and exposed products.CD does not permeate or become absorbed in materials to the same degree as other methods, greatly reducing the overall cycle time of the sterilization process and eliminating the lengthy post-sterilization aeration.


Low Residue Levels

CD’s properties combined with the rapid aeration process results in residues below detectable levels on product and packaging. CD’s sterilant residues are non-carcinogenic, non-cytotoxic and non-teratogenic. Sterilized packages and products may be handled immediately after the cycle.


Flexible to Design Custom Cycles

Process Parameter Range
CD Gas Concentration From 1 mg/L to 20 mg/L
Exposure Time Varies with Application
Door-to-Door Time 2-8 Hours
Relative Humidity Typically 65-90%
Depth of Vacuum 5-101 kPa
Chamber Temperature Ambient to 50°C

Compatible with Medical Device Materials and Packaging

Artificial Joints

CD is less oxidative than traditional oxidizing sterilants like hydrogen peroxide, ozone, NO2 and peracetic acid. ClorDiSys has tested many medical device materials including non-ferrous metals, polymers, batteries, tissues, bone products, and collagens. Compatible materials showed no increase in cytotoxic response. The true room temperature performance of the CD process allows temperature sensitive materials to be processed.
CD’s sterilization process is compatible with commonly used sterile barrier packaging. This includes: non-woven polypropylene, Tyvek® pouches, Tyvek®-Mylar® pouches, plastic tubs with Tyvek® lids as well as cellulosic materials such as paper and cardboard.



Compatible Materials*
Stainless Steel
Aluminum
Copper
Glass / Ceramic
Fluoropolymers
Most gasket materials
Polyethlene
Polypropylene
PET / PETG
Polystryene
Polysulfones
PEEK
Polyetherimide
Polycarbonate
Cycline Olefins
PVC
Silicone
Hypalon
Thermoplastic Elastomers
Titanium
Gold
Platinum
Cardboard
Most Inks
*This list is not exhaustive. Specific testing with your device is always recommended.

Current Applications

Below is a list of applications that CD gas has been used for. Please contact us for more information on any of these applications or to explore additional applications not listed below.

Sample Applications
Implantable Contact Lenses
Artificial Joints
Suture Products
Bones and Bone Powders
Surgical Kits
Datwyler Stoppers
Endoscopes
Electronic Devices