October 24, 2016
TPS Ships Gruenberg Sterilizing Oven for a Fully Integrated Pharmaceutical Company
Thermal Product Solutions (TPS), a global manufacturer of thermal-processing equipment, announced the shipment of a Gruenberg depyrogenation oven for a leading pharmaceutical company. The pharmaceutical oven will be used to sterilize and depyrogenate 5ml, 10ml, & 30ml glass vials. This unit meets ISO Class 5 (209e Full Class 100) sterilizing conditions throughout the process cycle at a maximum ramp rate of 1-1/2C per minute.
Gruenberg Sterilizers are designed and manufactured to comply with all pertinent current Good Manufacturing Practices (cGMP) requirements. There are HEPA filters installed in the air intake, exhaust, and recirculation wall to prevent cross contamination between different cycles as well as the external environment. A pass through design is provided with an automatic pneumatic door locking system, which is installed on both sterile and non-sterile side doors. Each door will automatically latch and remain locked in the proper sequence for pass through operation.
This Gruenberg oven has a maximum temperature rating of 536⁰ F and work chamber dimensions of 48”W x 69”D x 50”H. This sterilizer is designed with a stainless steel fully welded cove corner liner, complete stainless steel interior, and polished stainless steel exterior. A Bio-seal flange is provided to seal the sterilizer into the facility wall at the clean / sterile side of the system. This ensures a positive barrier preventing particulate from entering the clean room from the maintenance area. Gruenberg provides a standard 21 CFR Part 11 Ready control system that is equipped with Operator Interface Terminal (OIT) and Programmable Logic Control (PLC) technology.
“The Gruenberg brand specializes in pharmaceutical processing and offers the highest level of customer satisfaction. This sterilizer was designed to the customer’s requirements with a Bio-seal flange, stainless steel liner and interior that are ideal for a clean room environment.” – Greg Mitcheltree, Applications Engineer
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