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In-vitro Biological Reactivity
CLL launches in-vitro Biological Reactivity in packaging components, elastomers, medical devices, implants etc.
In-vitro Biological Reactivity as per USP <87> is used to determine the cytotoxic potential of any substance intended to be in direct / indirect contact with patient. Some of the materials that are required to be tested as per USP <87> are:
Polymeric packaging systems and their components (IV bags & tubes, pre-filled syringes, injection vials / stoppers etc.)
Elastomers
Medical devices and their components (Lenses, syringes, dental fillings, insulin pumps, patient contact devices etc.)
Implants
What is in-vitro Biological reactivity test?
Mammalian fibroblast, L-929, cells are utilized for cell culture. Test specimens or their extracts are placed in this cell culture and incubated at 37oC for 24-48 hours. The impact on cell monolayer is studied microscopically and graded from 0 (Non-toxic) to 4 (Severly toxic).
Three methods for Biological Reactivity defined by USP
| Method | Purpose |
|---|---|
Agar Diffusion Test | Elastomeric closures & components in a variety of shapes |
Direct Contact Test | Low- or high-density materials in variety of shapes, that could cause mechanical damage to the cells |
Elution Test | Extracts of polymeric materials |
Selection of the method depends on the type of material. All test methods require positive and negative controls to ensure that the test is valid. CLL uses original USP negative and positive controls from Hatano Research Center (Japan) as recommended by USP.
Regulatory Requirements
In-vitro Biological reactivity is referenced in a several USP chapters:
- 〈381〉, 〈1381〉 & 〈1382〉 for Elastomeric Components in Injectable Pharmaceutical Product Packaging / Delivery Systems.
- 〈661.1〉 Plastic Materials of Construction
- 〈661.2〉 Plastic Packaging Systems for Pharmaceutical Use
- 〈1031〉 The Biocompatibility of Materials used in Drug Containers, Medical Devices, and Implants
- 〈1046〉 Cell-Based Advanced Therapies and Tissue-Based products