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CBL currently fills a number of lyophilized products in its Hull 240 ft2, which can hold approximately:
- 60,000, 3cc vials
- 50,000, 5cc vials
- 40,000, 10cc vials
Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity. CBL has lyophilized syringe products of up to 120 tubs (100 syringes per tub).
Products that require lyophilization are filled, partially stoppered, and loaded into the pre-chilled lyophilizer throughout the filling period. CBL has two filling machine options (low or high speed) to ensure that the time from formulation to lyo cycle start is appropriate and minimized where possible. The lyophilizer, with external condensers, has temperature control to as low as –65°C and vacuum control between 50 and 1000 millitorr. A full load in the lyophilizer consists of 120 one foot by two foot trays.
CBL can steer clients who need development work on their lyo cycles to vendors who can design, and have designed, lyo cycles that have been successful when using CBL’s equipment. This can greatly increase the likelihood of success for clients with limited experience lyophilizing a particular product.
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