Pharmaceutical, Medical Device & Research Organizations
EO Terminal Sterilization
Simple & Scalable Solutions
For Pharma, Medical Device & Research Orgs
We Put YOU in Control
Innovative pharmaceutical and small medical device companies have not been well served by traditional sterilization companies. Andersen’s non-traditional and elegantly simple products and services are here to change the equation and put you in control.
Award Winning Innovation
We are THE Gas Sterilization Experts
Andersen has more than 60 years experience in this highly regulated industry, with 18 recent FDA clearances and six regulatory marks and approvals – including with EPA and ISO, as well as being OSHA-compliant. What do all those numbers add up to? Experience, expertise and leadership. Andersen remains actively engaged with critical regulatory agencies and governing bodies to ensure our systems not only meet standards, but in some cases, help establish them.
Andersen’s exclusive EO-Flexible Chamber Technology (EO-FCT) offers an array of distinct advantages:
- Achieves FDA-required 10-6 sterility assurance level for terminal sterilization of medical devices
- Micro-dose of EO (17.6g per cycle) – 90% less than any other system
- Maximum emissions, with abator – less than a pound a year (can be operated in all 50 states)
- Most gentle sterilization cycle currently available
- Low temperature – range of 68-131ºF, across all models
- No vacuum – atmospheric pressure chamber
- No steam injection – very low humidity cycles for delicate devices
- Scalable Process – add additional cabinets as your demand grows
- Easy, inexpensive installation
- Self contained unit – The liner bag acts as the sterilization chamber and the cabinet acts as a EO containment area or vent hood.
- No tanks, external compressors or fixed water lines
- Unmatched sterilization compatibility: Sterilize a wide range of delicate instruments, sharps, plastic, cellulose, rubber and other items that would degrade in your autoclave
Both solutions discussed below use the precise and reliable EO-FCT sterilization process.
One company, two solutions: Both safe, simple and scalable
It’s always good to have choices! Andersen offers you three sterilization strategies to choose from: Do it yourself in-house, outsource to our contract sterilization solution or use a combination of the two – as needed. See industry specific solutions and case studies below.
Make Sterilization Part of Your Production Process
Consider purchasing an Andersen sterilizer for in-house sterilization if you:
- Require sterilie processing of devices in smaller lots
- Are performing research (pharmaceutical company, contract research organization, laboratory or an academic institution)
- Have product under development, including clinical trials
- Manufacture custom devices and/or combination devices and drug products
- Have a product undergoing compatibility or functionality testing
Opting for In-House sterilization garners several benefits:
- Control every aspect of your sterilization workflow and improve your ability to manage inventory
- Reduced sterilization turnaround time
- Scalable, expand incrementally and virtually indefinitely based on your needs
- Reduced transportation costs and environmental impact
- Allowed in municipalities where other gas sterilizers are not, due to Andersen’s ultra-low emissions
Favorite for research organizations and R&D (because it is tabletop, easy to operate and easy to install). Two room temperature cycle options: 12- or 24-hours.
Rapid turnaround sterilization for custom devices, R&D and critical devices. Temperature-controlled tabletop unit with four cycles as fast as 3.5 hours (including aeration). Low temp for R&D and heated for those scaling-up to a validated manufacturing process.
Use this large volume system as part of a validated process. Great for bringing products to market. Expand capacity easily as production needs increase. Our customers are sterilizing up to 10 pallets a month with this option.
State-of-the-Art Facility Offering Custom Cycles and Fast Turnaround
Consider contract sterilization at Andersen’s award-winning, FDA-registered and ISO-approved facility (Andersen Scientific) if you:
- Require sterile processing of devices in smaller lots (less than 2 pallets)
- Require new custom cycle development and/or validation
- Need sterilization testing of new devices
- Need package validations for sealers, pouches and other packaging systems
Opting for Andersen Contract sterilization offers these benefits:
- In-depth R&D experience relative to sterilization
- Industry experts – Andersen representatives are longstanding members of the AAMI and ISO committees that create the standards used in the industry
- Rapid turnaround: devices/products can be sterilized and shipped back out within time frames, that meet your needs:
- Two weeks
- One week
- 24 to 48 hours
- Can customize cycles to meet your specific requirements
- Turnkey solution – finished product returned ready for distribution or can be shipped directly to customer/distributor
- Sterilization process
- Packaging (including sealer)
- Shelf-life & transportation studies
- Residual testing
- Contract sterilization
- Lab services
Industry Specific Solutions
No matter if you sterilize in-house or contract with Andersen, we have these industry-specific concerns and items covered!
Unparalleled Material Compatibility
Our exclusive EO-FCT process, cycle monitoring options and in-house/contract options make it possible to sterilize while ensuring the safety and stability of your pharmaceutical and biologic products.
With Andersen, achieve 10-6 SAL terminal sterilization of:
- Drug-device combination products
- Sealed combination drug-devices, such as drug-coated stents
- Sealed pre-filled syringes, vials or cartridges
- Bulk active pharmaceutical ingredients (API), excipients or ingredients
- DNA eradication from sampling devices such as swabs
- Chemical precursors and drugs – we will work with you to ensure that they are compatible with EO
- Production tubing and narrow lumens
- Vials and other containers
The Most Effective Sterilant – The Most Efficient Process
Over 50% of all new medical devices are sterilized with EO due to its effectiveness and material compatibility. Andersen EO-FCT sterilization offers the most gas effcient process on the market with zero emissions.
EO has the unique ability to penetrate many packaging materials, leaving your devices sterile and protected from contamination. Our precise and reliable EO-FCT process has the ability to sterilize very complex devices (mated surfaces, long narrow lumens, elevator mechanisms). Compatible with the widest range of devices including moisture- and temperature-sensitive materials (plastic, rubber and non-wovens) as well as electronics, robotics, fiber optics and batteries. Cycle monitoring and in-house/contract options give you added peace of mind and flexibility.
With Andersen, achieve 10-6 SAL terminal sterilization of:
- New devices undergoing prototyping, testing or trials
- Custom or semi-custom devices
- Devices with a short shelf life
- Polymer resin-based products
- Single-use medical devices
- Surgical staplers
- External sterilization of sealed pre-filled syringes, vials or cartridges
- Endoscopes, multi-channel devices with long narrow lumens
- Urological endoscopes
- Plastic or rubber devices
- IV Sets
- Plastic tubing & bloodlines
- Anesthesia masks
- Equipment with integrated electronics
- Heart valves & pacemakers
- Anesthesia circuits
- Surgical drills
- Fabric or cellulose items
- Wound care dressings
- Mixed-material items
- Procedure kits & surgical trays
In-House Case Study – Anprolene
Researchers at a leading university needed to sterilize pollen on a microbial level for a study on bee feeding habits. The sterilization method had to be gentle and effective. The team had been bogged down with a time-intensive process in-house and it didn’t want to risk contamination or delays by sending pollen out to be sterilized.
The university research team purchased an Anprolene AN74i. Anprolene is our most affordable option and the room temperature cycles are gentle enough…well…to sterilize pollen!
The sterilizer has made their process more “efficient and effective” so the doctors and their team can concentrate on what they do best. Note: Many facilities will install an inexpensive Anprolene unit in each lab to eliminate the possibility of cross-contamination.
In-House Case Study – EOGas 333
Over a decade ago, one of our manufacturing customers chose to bring sterilization in-house because they wanted control over every aspect of production and inventory management. They did not want to waste the energy and effort to ship product back and forth.
The company gained control over their supply chain and cut out shipping woes by purchasing an EOGas 333. By daily in-house sterilization of device production, small and medium manufacturers can achieve the aggregate capacity of one or more commercial EO pallet chambers.
With one cabinet the company reported they could sterilize up to 10 pallets of product per month. Our systems are inherently and uniquely scalable. As their demand grew they added additional EOGas 3 cabinets to achieve necessary capacity. Today, they run 10 EOGas 333 cabinets seven days a week. They can now sterilize up to 25 pallets per week or 100 pallets per month. Note: One way many customers gain efficiency is by only sterilizing the end product (not outer product/shipping packaging).
Contract Case Study
When the COVID-19 pandemic hit, authorities began requesting testing supplies and Keystone Solutions Group knew they could help. From first request to sending out swabs – it was just four weeks.
“Andersen Scientific was willing to jump in and understood how to get there,” said David Furchak, Launch Architect at Keystone. Andersen expedited the validation and packaging of Keystone’s swabs starting in March 2020. “The employees at Andersen have been good about figuring out the best path forward. Their collaboration and willingness to have conference calls at all hours is the key to success.”
Andersen sterilized two pallets per week from Keystone for over four months – during the peek of the pandemic. Generally, we were able to returned the swabs the day after receiving them.