Sterile Products

Characterization of sterile products can be a daunting task due to the complexity of balancing the analytics associated with confirmation of identification and potency, coupled with the safety considerations that are paramount to the release of a sterile product (e.g. sterility and endotoxin testing).

While sterile products all share the need to be free from microbial contamination, the types of products that fall into this broad category are quite diverse.  Sterile products include the following:

  • Injectables (parenterals)
  • Ophthalmics
  • Hydrogels
  • Medical Devices

Selecting an analytical partner that is well versed in the comprehensive analytical characterization of sterile products ensures you receive your time sensitive data in the timeframe that your production facility demands.  The services that BA Sciences offers for Sterile Products include:

  • Sterility Testing – Sterility testing is performed in Grade A Vaporized Hydrogen Peroxide (VHP) sterility isolators in an ISO 8 environment. Utilization of VHP isolators ensures sterility results are representative of sample matrix and not subject to contamination risk from the environment and analysts performing the testing.
  • Endotoxin Testing – BA Sciences offers endotoxin testing with all three USP <85> methodologies (Kinetic chromogenic, Kinetic Turbidimetric, and Gel Clot). Suitability is performed in order to understand the presence of any inhibiting or Enhancing factors prior to testing and the method sensitivity can achieve 0.005 EU/mL
  • Sterility Assurance Level (SAL) Bioburden Testing – Medical device manufacturing typically relies on terminal sterilization processes. In these manufacturing schemes, it is important to ensure the naturally occurring bioburden on the device and packaging components do not exceed the Sterility Assurance Level (SAL) established for the terminal sterilization method.  BA Sciences are experts on Bioburden testing of Medical Devices and execute validation and routine bioburden testing according to ISO 11737.
  • Stability Testing – BA Sciences offers full service stability management and testing. Specific ATMP stability considerations are in place at BA sciences to ensure product specific considerations are encompassed, including freeze-thaw studies and forced degradation evaluations. Our service offerings include stability methods development and validation, and routine stability testing.  BA Sciences can manage the stability testing program from start to finish, including sample management & storage, routine sample testing at each timepoint, data trending & analysis, and CoA delivery. 

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