Bulk Lyophilization 2019-07-26T13:47:51+00:00
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Bulk Lyophilization

Bulk Lyophilization

With more than 20 years of experience in bulk freeze drying, LSNE can quickly and expertly handle large-scale bulk lyophilization, harvesting and packaging of your medical device, drug intermediate or API.

  • Lyophilization performed under ISO 8 conditions
  • Regulatory-compliant facilities
  • Dedicated stainless steel trays or Lyoguard® trays
  • Harvest/Packaging
  • Formulation/Filtration
  • Up to 400 L capacity
  • 260 ft.2 of lyophilizer shelf space
  • Inert gas back-fill capability

LSNE offers full, flexible bulk lyophilization development services tailored for medical devices, drug intermediates and APIs, including development of formulations, lyophilization cycles and product sampling, testing and packaging. We can implement dedicated programs for individual products, and we have a proven record of shortening lyophilization cycles to reduce costs over a product’s lifespan.

With 260 ft.2 of lyophilizer shelf space, we have capacity for 195 disposable Lyoguard® trays — so we can maximize the output of each batch. We can also design and manufacture dedicated and reusable lyophilization trays to fit the specific needs of your product and process. If required, we offer containment systems for the compounding and harvesting of more-potent compounds.

To protect your valuable product during processing, our lyophilization facilities have complete backup power and redundant vacuum pumps and compressors.

If bulk lyophilization is an intermediate step, we can efficiently transfer the product to you — or eliminate tech transfer by processing the material in our full-service formulation, filtering, and vial-filling facilities.