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ProSys Technology provides an expansive range of Containment products for the Pharmaceutical industry, custom-designed and fabricated in-house, for our global client base. Our proven designs have been successfully independently validated to protect operators and the surrounding area down to a single digit nanogram CPT (Containment Performance Target) levels, whilst handling the most potent of HPAPI’s (High Potent Active Pharmaceutical Ingredients).
We have recently delivered a Potent Powder Handling Isolator that requires low relative humidity conditions.
The Isolator was to be designed to suit personnel protection when handling potent molecules with inert, low humidity for the production of inhalation products. The OEL of the powders being handled was 0.1μg/m³ and the Isolator needed to maintain <5%RH.
In addition, the customer stated the following requirements:
UL certified components
- Height adjustable lower support frame, with seismic calculations for anchoring
- Isolator inner chambers to be Class II, Division I, Group G rated for combustible dusts
- Isolator to incorporate two balances within the working chamber along with adjacent working space
- The Isolator to provide an inert Nitrogen environment
- Isolator to include UV protection for Powder Handling
To ensure we had achieved our client’s requirements, two product types were handled in the Isolator. The first were excipients which were not potent but required low humidity during weighing and dispensing. These products will be placed into the main chamber via the front window, that features a lift-up, Excipient containers will be stored on shelves within the Isolator. The window is closed and sealed so the Nitrogen purging process can begin. Once the main chamber has achieved <5% RH, processing can then commence.
The second product type is spray dried and will require both humidity control and containment to an OEL of 0.1μg/m³. EN689-2018 says we must achieve 10% of desired OEL (Containment Performance Target – CPT). Therefore, we included a transfer chamber connected to the main weighing chamber. A bag port was connected to this chamber to bring the spray dried product into the Isolator system and allow the exiting of final weighed materials out of the Isolator system. Spray wands and floor drains were provided to clean both the transfer chamber, and the main weighing chamber, assuring the required Containment Performance Target level. This design also allows for N2 purge or the smaller transfer chamber to desired RH before passing materials in or out of the main weighing chamber.
A particular challenge was meeting the seismic requirement for California while designing a height adjusting, mobile lift stand.
The preliminary design (see left) was reviewed at length resulting in a final design which increased the length of the main chamber, through an additional glove port. The support frame size and casters were increased to meet the appropriate seismic calculations while maintaining its lifting capability.
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Once the design had been finalised and approved, its features included:
Main Weigh Chamber
- Nominal dimensions 1800mm wide x 500mm deep x 900mm
- Typically operating at -100pa
- Full pressure control circuit (PCC) with glove off condition
- Single stage inlet HEPA filter
- Double stage outlet HEPA filters
- Lift-up front window with a single row of 5 gloves with inflatable silicone seal
- Inner hinged door in left hand wall allows movement of product into main chamber from airlock
- RH monitoring
- Integration of customer supplied weigh scales and displays
- Manual wash hose with gun (s) to aid cleaning with water / other cleaning solutions with external manual ball valve
- Sloping base for individual drainage via dedicated manual ball valve
Transfer Chamber
- Nominal dimensions 1000mm wide x 6000mm deep x 900mm high
- Typically operating at -50pa
- Full pressure control circuit (PCC) with glove off condition
- Lift up front window with a single row of two gloves with inflatable silicone seal
- 500mm Bag in Bag out port bag over bag style for single bag connection
- RH monitoring
- Manual wash hose with gun(s) to aid cleaning with water / other cleaning solutions with external manual ball valve
- Sloping base for individual drainage via dedicated manual ball valve
FAT on the Isolator included
- Mechanical checks
- Dimensional checks
- Surface finish (internal and external)
- Electrical checks
- Electrical continuity
- Functionality testing
- Sound level check
- Riboflavin test of WIP coverage
ProSys Technology approaches every project as our customer’s partner, to assist them in producing an Isolator System that it the best solution for their process and operators. Get in touch today to find out more!
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