Combination product incoming-to-lot release testing

Lot release sample storage

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.

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

Functional testing including essential performance requirements

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.

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).

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