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)
Patents
Micropatterning technique for creating morphologically specific free-floating structures for use as standards in the pharmaceutical industry
US-10006870-B2
View Details
Micropatterning technique for creating morphologically specific free-floating structures for use as standards in the pharmaceutical industry
US-10006870-B2
View DetailsProducts
Combination Product
Analytical testing services to evaluate compatibility of drugs with primary containers and generate data in a GMP Lab to support drug combination product regulatory submissions.
Combination product incoming-to-lot release testing
Lot release testing services for combination products from incoming stages onward.
Container Closure Integrity
Comprehensive container closure integrity testing and analysis services using deterministic and probabilistic methods for pharmaceutical, biotech, and medical device packaging systems.
Container Closure Integrity Testing
Testing service to evaluate whether a given container maintains its sterile barrier during the design verification phase.
Small-Scale
ZebraSci provides GMP production filling, assembly, and labeling for not-for-human-use (NFHU) small volumes, supporting complex combination product testing and device sample needs.
Small-scale fill/finish & assembly (NFHU)
Small-scale fill-finish and parenteral device assembly services.
Combination Product
Analytical testing services to evaluate compatibility of drugs with primary containers and generate data in a GMP Lab to support drug combination product regulatory submissions.
Combination product incoming-to-lot release testing
Lot release testing services for combination products from incoming stages onward.
Container Closure Integrity
Comprehensive container closure integrity testing and analysis services using deterministic and probabilistic methods for pharmaceutical, biotech, and medical device packaging systems.
Container Closure Integrity Testing
Testing service to evaluate whether a given container maintains its sterile barrier during the design verification phase.
Small-Scale
ZebraSci provides GMP production filling, assembly, and labeling for not-for-human-use (NFHU) small volumes, supporting complex combination product testing and device sample needs.
Small-scale fill/finish & assembly (NFHU)
Small-scale fill-finish and parenteral device assembly services.
Services
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.
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.
Characterization of silicone oil distribution and lubricant profiles on primary container components, plus material change verification programs addressing functional performance, particle formation and stability.
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.
Design control support, device verification, usability/human factors testing, transit simulation and shelf‑life/stability evaluations required for commercialization of combination products.
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.
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.
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.
Characterization of silicone oil distribution and lubricant profiles on primary container components, plus material change verification programs addressing functional performance, particle formation and stability.
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.
Design control support, device verification, usability/human factors testing, transit simulation and shelf‑life/stability evaluations required for commercialization of combination products.
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
News & Updates
ZebraSci expands its laboratory facilities in Branchburg, NJ, to support the growing demand for device development and testing services in the East Coast and globally.
The company has obtained ISO 13485 certification, demonstrating compliance with international standards for medical device quality management.
Introduction of new testing capabilities for audible medical devices, enhancing product development and quality assurance.
Providing solutions to streamline device integration and reduce development costs for medical devices.
Discussion on temperature requirements and logistics for vaccine distribution, including cold chain considerations.
Details about the company's certification and what it means for quality management.
ZebraSci expands its laboratory facilities in Branchburg, NJ, to support the growing demand for device development and testing services in the East Coast and globally.
The company has obtained ISO 13485 certification, demonstrating compliance with international standards for medical device quality management.
Introduction of new testing capabilities for audible medical devices, enhancing product development and quality assurance.
Providing solutions to streamline device integration and reduce development costs for medical devices.
Discussion on temperature requirements and logistics for vaccine distribution, including cold chain considerations.
Details about the company's certification and what it means for quality management.