Combination product incoming-to-lot release testing

Get support in managing incoming inspection tests and lot releases.

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We can support manufacturing and quality organizations with incoming inspection testing of raw materials:

Visual inspection
Sub-visible particle
CCI
Package testing
Mechanical performance
Dimensional analysis (w/ inspection)

Incoming inspection testing can be related to mechanical performance testing, lubrication inspection, dimensional measurements, or other customer requested inspections.

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Container closure integrity (CCI)

Analytical Testing

Siliconization testing and analysis

Primary container & device functionality testing

Drug combinationproduct design verification

Small scale fill & finish and assembly

Complaint sample handling and root cause investigation

Combination product incoming to lot release testing

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Select the service/s you request information

Container closure integrity (CCI)Analytical TestingSiliconization testing and analysisPrimary container & device functionality testingDrug combinationproduct design verificationSmall scale fill & finish and assemblyComplaint sample handling and root cause investigationCombination product incoming to lot release testingAdditional Services

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VIEW CAPABILITIES

Lot release sample storage

ZebraSci can log and store your samples at a variety of temperature and humidity ranges, depending on your sample needs. All of our storage chambers are calibrated and meet your target product storage conditions before any testing begins.

Five syringes of varying colors displayed against a pink background.

Image of the BD Hypak™ glass pre-fillable syringes for anticoagulant.

Functional testing including essential performance requirements

We have numerous capabiltiies to support device essential performance requirement (EPR) testing for your intended combination product. We have in-house methods to test all kinds fo combination products and these same methods are used for incoming and lot release testing. Our experts understand the importance of testing EPRs to demonstrate that the devices will meet all user needs and can guide you on which EPRs you should focus on as part of incoming or lot release testing.

two syringes of varying colors displayed against a pink background.

Image of the BD Hypak™ glass pre-fillable syringes for anticoagulant.

Drug product & placebo in vials

Drug product & placebo

ZebraSci is known in the industry as combination product experts. As such, we have capabilities to support lot release testing for both drug product-filled and placebo-filled combination products. Product quality and device functionality testing are essential to demonstrate that your drug product lots meet your product quality requirements and/or essential performance requirements (EPRs).

one syringes of varying colors displayed against a pink background.

Image of the BD Hypak™ glass pre-fillable syringes for anticoagulant.

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