New USP <382>
USP <382>, titled “Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems,” is a new United States Pharmacopeia chapter that becomes official on December 1, 2025.
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Container Closure Integrity (CCI)
Container Closure Integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development.
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Siliconization of the syringe barrel is critical for efficient mechanical performance of prefilled syringes in drug-device combination product as adequate, consistent silicone oil coverage is necessary for smooth stopper movement within the syringe’s glass body, supporting a complete and smooth injection.
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Extractables & Leachables
E&L studies aim at identifying what compounds could be extracted into a drug product formulation under normal conditions of production, storage and use.
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With a robust offering specializing in Combination Product Development, we give clients access to the information they need to make confident decisions. Use our request feature to begin our partnership
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Testing services
Combination product development is a complex journey with many potential pitfalls that can cause delays in the development timeline. Learn how ZebraSci can assist you in avoiding these difficulties.
Our commitment to our customers
For more than a decade, ZebraSci has built a legacy based on streamlined solutions, dependable service and technical expertise. We provide pharmaceutical, biotechnology, and medical device companies with development, manufacturing and testing services, helping clients overcome their most difficult primary container and drug delivery device challenges. ZebraSci service capabilities support the development of drug-device combination products with both BD and non-BD devices.
