Zebrasci
ZebraSci is a leading provider of inspection, testing, and development solutions for the pharmaceutical, biotechnology, and medical device industries. With a focus on innovative technologies, regulatory compliance, and customer service, ZebraSci supports clients from concept to market, helping accelerate device development, ensure quality, and facilitate regulatory approval. The company offers a comprehensive range of services including container closure integrity testing, analytical testing, siliconization analysis, device functionality testing, and specialized combination product testing and advisory. ZebraSci is committed to supporting clients throughout the product lifecycle, from development to commercialization, with a strong emphasis on quality, innovation, and regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Zebrasci
Temecula, California, United States, North America
Products
Combination Product Development
Specializes in the development of combination products, providing clients with the necessary information to make informed decisions.
Container Closure Integrity (CCI) Testing
Evaluates whether a container maintains its sterile barrier, a mandatory step in the design verification phase of drug-device combination product development.
Combination Product Testing
Offers end-to-end pharma packaging and drug stability testing services, including particle generation measurement, drug product stability, and silicone interaction with drug products.
Silicone Characterization for Containers
Uses FlexHD technology to assess lubricant oil quantity and distribution in primary containers for parenteral applications, providing non-destructive evaluation of silicone distribution and quantity.
Drug Delivery Device Selection and Evaluation
Assists in selecting the right components or optimizing drug delivery devices to existing containers, ensuring reliability and performance.
Drug Device Design Verification
Validates drug-device combination product development with analytical and functional testing strategies to ensure design outputs meet input requirements.
Combination Product Development
Specializes in the development of combination products, providing clients with the necessary information to make informed decisions.
Container Closure Integrity (CCI) Testing
Evaluates whether a container maintains its sterile barrier, a mandatory step in the design verification phase of drug-device combination product development.
Combination Product Testing
Offers end-to-end pharma packaging and drug stability testing services, including particle generation measurement, drug product stability, and silicone interaction with drug products.
Silicone Characterization for Containers
Uses FlexHD technology to assess lubricant oil quantity and distribution in primary containers for parenteral applications, providing non-destructive evaluation of silicone distribution and quantity.
Drug Delivery Device Selection and Evaluation
Assists in selecting the right components or optimizing drug delivery devices to existing containers, ensuring reliability and performance.
Drug Device Design Verification
Validates drug-device combination product development with analytical and functional testing strategies to ensure design outputs meet input requirements.
Services
Container closure integrity (CCI) testing
Laboratory CCI testing programs using multiple methods (helium tracer, vacuum decay, electrical leak detection, headspace analysis and dye methods) for design verification and lot release of syringes, pens, auto‑injectors and vials; scalable from benchtop to production settings.
Analytical testing (E&L, method development)
Extractables and leachables studies with AET calculation, toxicological report assessment, analytical identification/quantitation, and development/validation of targeted analytical methods to support regulatory submissions and stability testing.
Silicone inspection and lubrication profiling
Characterization of silicone oil distribution and lubricant profiles on primary container components, plus material change verification programs addressing functional performance, particle formation and stability.
Primary container & device selection and evaluation
Consultation and testing to select and qualify primary containers and delivery devices, including dimensional metrology, RSF/compression analysis, compatibility assessments and feasibility studies to inform device selection and regulatory strategy.
Drug–device combination product design verification
Design control support, device verification, usability/human factors testing, transit simulation and shelf‑life/stability evaluations required for commercialization of combination products.
Small‑scale fill–finish & assembly
Laboratory and clean‑room fill–finish and assembly operations to support early‑stage development, pilot production, stability studies and lot‑release testing for combination products.
Container closure integrity (CCI) testing
Laboratory CCI testing programs using multiple methods (helium tracer, vacuum decay, electrical leak detection, headspace analysis and dye methods) for design verification and lot release of syringes, pens, auto‑injectors and vials; scalable from benchtop to production settings.
Analytical testing (E&L, method development)
Extractables and leachables studies with AET calculation, toxicological report assessment, analytical identification/quantitation, and development/validation of targeted analytical methods to support regulatory submissions and stability testing.
Silicone inspection and lubrication profiling
Characterization of silicone oil distribution and lubricant profiles on primary container components, plus material change verification programs addressing functional performance, particle formation and stability.
Primary container & device selection and evaluation
Consultation and testing to select and qualify primary containers and delivery devices, including dimensional metrology, RSF/compression analysis, compatibility assessments and feasibility studies to inform device selection and regulatory strategy.
Drug–device combination product design verification
Design control support, device verification, usability/human factors testing, transit simulation and shelf‑life/stability evaluations required for commercialization of combination products.
Small‑scale fill–finish & assembly
Laboratory and clean‑room fill–finish and assembly operations to support early‑stage development, pilot production, stability studies and lot‑release testing for combination products.
Expertise Areas
- Combination product development and design control
- Container closure integrity and package performance testing
- Extractables & leachables programs and toxicological assessment
- Analytical method development and validation
Key Technologies
- Helium tracer leak detection
- Vacuum decay leak testing
- High‑voltage electrical leak detection (microcurrent)
- Headspace gas analysis