Why Are Bio-Seals Required on Some Steam Sterilizers?
Bio-Seals provide a containment barrier between two separate biologically classified areas. BioSeals are primarily used on double door sterilizers. However, some are applied to singe door sterilizers to separate the service area.
Laboratories and Biological Safety Levels (BSL)
There are multiple levels of BSL laboratories:
- BSL-2 Lower-level containment that may not require a Bio-Seal
- BSL-3 Higher level bio-containment that requires a Bio-Seal
- BSL-4 Highest level bio-containment that requires an Enhanced BioSeal mechanically fastened and sealed per stringent guidelines established by the U.S. Department of Health and Human Services for the National Institutes of Health and Centers for Disease Control
Different Types of PRIMUS Bio-Seals
Vermin Seals (Option V6)
A Vermin Seal is a metal-on-metal seal mechanically fastened without sealant. This seal is used
primarily to keep laboratory animals contained between different classified labs and or areas.
Air Differential Seals (Option V6-1)
Air Differential Seals are similar to Vermin Seals except sealant is applied to create an air differential between two different laboratory classifications that do not have to be 100% airtight. A vapor-proof flange is welded to the pressure vessel on both sides of the flange and around its full circumference. Penetrations through the flange for electrical and piping components are secured with vapor-proof fittings.
Enhanced Bio-Seals (Option V12)
A Biological Seal consisting of a steam sterilizer with a Bio-Seal flange integrated to a fully gasketed seal allowing for movement of the sterilizer. Bio-Seals are metal-on-metal or metal-tosilicone-to metal to form fully a gasketed seal. The seal is mechanically fastened by locking bars and bolts to stainless steel panels attached to embedments in the building architecture, thus providing a complete containment barrier.
Bio-Seal Fully Welded Box (Option V11)
A fully welded stainless steel box welded to the BioSeal Flange forming a complete Bio-Seal.
How PRIMUS Approaches Bio-Seals
Sterilizer Bio-Seal Flange
Regardless of seal type, the Bio-Seal flange is 100% seal welded to the sterilizer pressure
vessel.
BioSeal Extension Panel System
Bio-Seal Extension Panel Systems are available in .050 aluminum, stainless steel, or stainless
steel to silicone gasket to stainless steel depending on the specific requirements of the project.
Bio-Seal extension panels require accurate measurement to ensure the extension panels fit
properly.
Connection to Building Architecture
Mechanically attached to building infrastructure either directly or to an embedded metal frame.
Enhanced Bio-Seal Requirements
Enhanced Bio-Seal installation requires the following in order to install the Bio-Seal properly:
- A meeting prior to installation to discuss and review the Scope of Work and project-specific requirements is required. All Bio-Seals must be installed by PRIMUS directly or by PRIMUS Authorized Service Agents (ASA) trained in the proper installation of Bio-Seals.
- Prior to a job being turned over, a final review must be performed to ensure the work has been performed per PRIMUS requirements and meets the project guidelines and/or specifications.
Additional Requirements for Steam Sterilizers in Bio-Safety Applications
Bio-Seal Software Interlocks – On Bio-Seal steam sterilizers, the load side or Side A is considered to be the contaminated (dirty) side. The unload side or side B is considered to be the uncontaminated (clean) side.
The door interlock logic has two basic rules:
- Both doors can never be open or even unsealed at the same time
- If the door on the dirty side has ever been opened or unsealed, the door on the clean side may NOT be unsealed or opened until the chamber is sterilize. To achieve sterility a clean-up cycle must be run. If the clean-up cycle is not conducted it would move dirty air into a clean environment
Note
If the door on the clean side has been opened or unsealed, it is allowable to close and seal it
and open the dirty side without running a cycle since it simply moves clean air into a dirty
environment.
Refer to Did You Know? #11 for additional information on Bio-Seal software interlocks and door controls.
General Information
PSS500 Control System requires a clean-up cycle to be run in one process flow direction only.
PSS8 Trinity Control System allows for configuration that requires a clean-up cycle to be run in either direction.
Be certain which side (or both) of the sterilizer the printer needs to be mounted.
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at dschall@spire-is.com.
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