Validated Cold Room/Freezer Combination Now Operational - Masy Systems

Masy Systems BioPharma Storage Facility Update


Bahnson / Environmental Specialties Cascading Walk-In ChamberIn past announcements, mention was made of a large refrigerator/freezer combination unit being assembled for Masy Systems by Bahnson Environmental Specialties at our Pepperell location. We are very pleased to announce that this state of the art unit has completed commissioning and validation and is now ready for product.

The unit, one of three in the United States, is entered through a 4´ wide door into a refrigerated room of 3900 cubic feet capacity, allowing the storage of bulk product. This monitored 5°C space has two cooling units to provide redundancy; each system independently capable of maintaining temperature. For storing customer product, Masy has installed custom rolling racks consisting of individual adjustable shelves that are 3´W x 8´ L x 11´ H with space set aside for the storage of drums and pallets.

The sole entry point into the adjacent 3900 cubic foot -20°C room is through another 4´ door from the refrigerated room. This space is similarly maintained by two independent cooling systems. The space is also provided with very dry pressurized air to significantly reduce any frost or ice build up. Custom rolling racks identical to those in the refrigerated space provide maximum efficiency in space utilization.

Built into the -20°C room is a -80°C six door vault that has approximately 1100 cubic feet of storage space. Built-in racks with sliding bins provide the ability to quickly access product. The vault has four separate and distinct cooling systems; two traditional coils maintained by separate condenser/compressor skids, cooling coils into which LN2 can be introduced and a backup CO2 capability. Supplies of both gases are maintained at Masy Systems guaranteeing availability in emergency situations.

The two rooms and the vault are monitored by our validated Masy Commander monitoring system. All three spaces have been validated in empty and full conditions to determine minimum/maximum temperature locations for the Commander monitoring sensors in each. The Commander records temperature (and where required, humidity) data every 10 seconds and provides the foundation for dial out alarms to alert the Masy staff of any out of tolerance situations. Redundant to this system, there is a datalogger recording temperature in the mean location in each room in addition to the individual unit room controller alarms.

This unique cascading design from 5°C, to -20°C to -80°C, allows for ultra-efficient utilization of power and floor space. Provided with the 6" thick walls, a dedicated dry air system and other features, these three environments provide very cost effective storage for non-segregated products and allows us to offer very economical storage as compared to stand alone walk-in units.

Power back-up for the combination unit is a pair of 450 Kva Cummins generators, each with 600 gallon diesel fuel tanks. Two automatic transfer switches control the generators providing a nearly instantaneous resumption of power to the building when power outages occur. A single generator is capable of powering the entire Masy Systems facility for up to 3 days, providing a long term source of power during an extended outage.

With the commissioning of this combination unit, Masy has dramatically increased our capability to store product from -80°C to 5°C. Previously we commissioned large walk-in or dedicated reach-in chambers at the ICH stability conditions (25°C/60%RH, 30°C/65%RH, and 40°C/75% RH). Masy also has LN2 freezer and monitored ambient storage space available.

Our ability to pick up and store product per GMP requirements provides customers a streamlined chain of custody, minimizing concerns for product in transit to an off site storage location. Once here, Masy provides state of the art secure storage maintained by a fast reacting staff prepared to work with customers to assure peace of mind for valuable resources. Multiple safeguards, redundancies and our robust Quality systems are the building blocks on which the Masy BioPharma Storage facility was planned. With the addition of the cascading unit, we offer an extremely wide range of storage options at very competitive rates.

If you would like additional information or a tour of the Masy BioPharma Storage facility, please to contact us. Masy is committed to safeguarding your critical biomaterials while they are in our care. Please consider joining us at the Ribbon Cutting ceremony for the BioPharma Storage facility during our September 24th Open House.

 
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