Gruenberg Pharmaceutical Sterilizers and Depyrogenation Ovens
Gruenberg designs and manufactures a complete line of standard and custom pharmaceutical sterilizers and depyrogenation ovens. Pharmaceutical sterilizer configurations include laboratory, cabinet, truck-in, pass-through, and continuous arrangements. Pharmaceutical sterilizers and depyrogenation ovens are designed to reach maximum temperatures up to 536°F (280°C). All sterilizers are custom designed for your specific temperature and cycle time requirements.
The control systems can be self-sufficient relay logic or PLC, or they can be integrated with your process PLC.
More standard features than competing products!
| | Gruenberg S-Series | Competing Models |
|---|
| 21 CFR Ready Controls | Standard | Option |
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| Pressure Locks | Standard | Option |
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| Web-Based Service Connectivity | Standard | Option |
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| Factory Acceptance Test | Standard | Option |
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Pharmaceutical Sterilizer Features- Heavy-duty, fully-welded, structural steel frame
- Exteriors constructed of 16 and 18 304L stainless steel with a #4 polish to withstand frequent wash downs
- Side walls and loading tracks are removable for easy clean-up and maintenance.
- HEPA filters installed on the air intake, exhaust, and recirculation air flow to ensure a class 100 environment
- Interior chamber seams are 100% continuously heliarc welded to eliminate risk of process contamination
- Custom trucks, trays, and transfer carts are available
Class 100 Sterilizer Guaranteed Class 100 Conditions
To maintain class 100 quality throughout the process chamber, HEPA filters are installed in the air intake, exhaust and recirculation wall.
The HEPA filters are a minimum 99.97% efficient at 0.3 microns.
The intake HEPA filter prevents contaminates from entering the sterilizer during operation.
The exhaust HEPA filter ensures that contamination will not be drawn into the sterilizer as the cycle ends.
Side wall filters provide distinct advantages.
Filtration takes place just before the air enters the sterilization chamber so that class 100 conditions are ensured. Plus, they afford easy access to filters for validation and maintenance.
Gruenberg S-Series Sterilizer Standard Features
Designed and manufactured to comply with all pertinent cGMP requirements. Interior is manufactured with a fully welded 304L-2B stainless steel liner. All interior corners are rounded with a ¾” radius to provide ease of wipe downs.
Standard Sterilizers are rated for 536°F (260C°) depyrogenation
ISO14644-1, ISO Class 5 (209e Full Class 100) sterilizing conditions throughout the process cycle (1.5°C / Minute ramp rate, with option of rapid capacity filters up to 10°C/minute ramp rate.) HEPA filters are installed in the air intake, exhaust and recirculation wall. The intake HEPA filter prevents contaminates from entering the sterilizer during operation and is protected with an upstream prefilter. The exhaust HEPA filter ensures contamination will not be drawn into the sterilizer at the cycles end. Side wall filters provide filtration immediately prior to the process air entering the sterilization chamber.
A Bio-seal flange is provided to seal the sterilizer into the facility wall at the “clean” side of the system and ensures a positive barrier preventing particulate from entering the room from the maintenance area.
Pass Through with interlocked Pressure Sensitive doors. The doors are provided with a pneumatic latching and locking system. The door will latch automatically and will remain locked to provide proper pass-through operation.
- UL Listed Control Panel.
- Lockable Disconnect Switch on Control Panel Door. Lockout Tagout capable.
- Both Control Systems are 21 CFR Part 11 Ready.
Pharmaceutical Sterilizer Optional Equipment
- Accelerated Sterilizer Cycle Time (10°C / minute)
- The standard HEPA filters will be replaced by advanced filters that can operate under greater differential thermal expansion. In addition to the upgrade in filtration, the system will require additional heat input to maintain the accelerated heat up rate.
- 316L Stainless Steel Interior
- Cooling Coil in Intake Stream
- Pressure Differential Control System
- GAMP 4 Documentation
- IQ/OQ Protocols (unexecuted or executed) Full validation documentation in accordance with the GAMP regulations.
- Isolator compatible
- Stainless steel trucks and trays in standard and custom sizes.
Custom Sterilizer Configurations Available
All sterilizers are designed for your specific temperature and cycle time requirements.
Sterilizer Automated Process Controls 
Gruenberg offers the standard control system with the S-Series line and the SCADA control system as an option.
STANDARD CONTROL SYSTEM
As a standard feature, Gruenberg provides a 21 CFR 11 ready control system equipped with PLC and OIT (Operator Interface Terminal) technology. The Allen Bradley Compact Logix PLC with on board Ethernet communications to connect to the Allen Bradley Panelview Plus 700 touch screen OIT. The Panelview Plus offers a TFT color screen, on board Ethernet connectivity, network security and audit trail capabilities (using A/B Factory Talk) for 21 CFR applications, data logging, alarm logging and the ability to store up to 10 recipe profiles.
A multitude of screens offer the customer user friendly interfaces for security, maintenance screens including auto-tune, recipe generation and storage.
SCADA CONTROL SYSTEM
The SCADA (Supervisory Control and Data Acquisition) control system comes equipped with PLC and HMI (Human Machine Interface) technology. The Allen Bradley Compact Logix PLC with on board Ethernet communications to connect to a desktop or panel mounted touchscreen PC.
The PC is loaded with Windows and Wonderware’s Intouch 8.0 - HMI for standard or custom designs to meet the customers control system requirements.
The HMI comes complete with field installed and validated 21 CFR Part 11 ready control and data acquisition system.