INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Tema Sinergie AB-PTC Series is a comprehensive range of Pass Through Box (cGMP Class A/ISO 5) designed for pharmaceutical companies that require an isolated environment for external bio-decontamination of materials prior to their transfer into classified environments.

  • Advance biologic and bioconjugate programs with unified platforms, scalable GMP manufacturing, and specialized capabilities that move teams efficiently from early design to clinical readiness.

  • Active bead release gives manufacturers precise control over T cell isolation timing, phenotype preservation, and workflow efficiency, eliminating multi-day passive dissociation delays.

  • A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).

  • The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.