Applications: Medical Devices

applications

medical devices

In the medical device industry, contamination control and sterility are crucial components to maintaining the highest level of quality products expected of companies in these fields. RMP ENVIRONMENTAL offers many chlorine dioxide based decontamination products and services to preserve your product integrity and trust. Our CD gas is registered with US Environmental Protection Agency as a sterilant and is able to inactivate all forms of antimicrobial life, including spores.Our chlorine dioxide (CD) gas is gentle on materials and is the safest and most effective way to decontaminate your isolators, processing rooms, and passthroughs and is a direct replacement for EtO.

CD gas has been providing true sterilization, similar to EtO, for medical devices for over 25 years. While EtO is a very effective sterilant, CD gas has many benefits over EtO for a variety of applications. Both are gasses which have the ability to reach all of the individual organisms to provide desired SAL levels utilizing 6-log sporicidal BI’s. The CD gas concentration can easily be measured with a built-in UV-VIS spectrophotometer ensuring the efficacy of every cycle and allowing for parametric release. Unlike vapor methods, Chlorine dioxide, being a gas, offers repeatable and consistent kill. Unlike some novel gas methods, CD has over 25 years of use since it was developed by Johnson & Johnson for sterilizing suture products, artificial joints, and implantable contact lenses.

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 true 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.

CD is also not listed as a carcinogen. 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.

Treatment is cost effective.

THE CD GASADVANTAGE

  • 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 - 1 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 DESIGNCUSTOM CYCLES

Process Parameter

Range

CD Gas Concentration

  • From 1 mg/L to 20 mg/L

Exposure Time

  • 1-8 Hours

Door-to-Door Time

  • Varies with Application

Relative Humidity

  • Typically 65-90%

Depth of Vacuum

  • 5-101 kPa

Chamber Temperature

  • Ambient to 50°C

FLEXIBLE TO DESIGNCUSTOM CYCLES

Process Parameter

Range

CD Gas Concentration

  • From 1 mg/L to 20 mg/L

Exposure Time

  • 1-8 Hours

Door-to-Door Time

  • Varies with Application

Relative Humidity

  • Typically 65-90%

Depth of Vacuum

  • 5-101 kPa

Chamber Temperature

  • Ambient to 50°C

COMPATIBLE WITHMEDICAL DEVICE MATERIALS AND PACKAGING

CD is less oxidative than traditional oxidizing sterilants like hydrogen peroxide, ozone, NO2 and peracetic acid. RMP ENVIRONMENTAL  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.

CompatibleMaterials*

  • 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.

currentapplications

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.

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