INSIGHTS ON LIQUID DOSE MANUFACTURING

LIQUID DOSE MANUFACTURING SOLUTIONS

  • Many of today's biopharmaceutical formulations may potentially suffer from oxidation to some degree. Large molecule formulations are relatively more delicate and may be prone to degrade in the presence of oxygen.  Besides a loss of efficacy and reduction in shelf life, exposure of such products to oxygen can result in product discoloration, changes in dissolution rate and profile, and even toxicity or other pharmacological properties associated with negative side effects. During the development of an oxygen-sensitive product, studies are performed that investigate the formulation’s interaction with oxygen. End-of-shelf-life stability studies verify that the product indeed retains efficacy under specified headspace oxygen levels. Such studies allow for the specification of appropriate initial headspace oxygen levels in the primary packaging.

  • Lyophilization processes require quality design and high performance containment systems. Dec also offers automated solutions for loading and unloading freeze-drying systems.

  • With over 70 years of experience in glass production, Stevanato Group, through its historic Ompi brand, is currently the market leader in cartridge manufacturing.

  • Stevanato Group through its historical brand Ompi provides a wide range of washed, siliconized and pre-sterilized EZ-fill® syringes systems. Available in a range of sizes from 0,5 ml to 5 mL with staked needle, Luer cone or Luer lock adapter. Bulk syringe systems are available with or without staked needle and provided in trays.

  • Used MG2 continuous motion capsule filler, model Planeta100, nominally rated up to 100,000 capsules/hour, currently set up for microdose capsules, multinet weight control unit less scale system, 460 volt, serial# 4697, built 2014.