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Pharmaceutical Primary Packaging

State-of-the-art Phase I – Phase IV Packaging

Our primary packaging capabilities feature scalable options to meet the varying needs of each trial, from small Phase I studies to the largest Phase III and Phase IV programs.

Primary packaging is performed in our state-of-the-art packaging suites meeting rigorous GMP standards for investigational medicines. Packaging is performed in validated conditions with individual air handling, temperature and humidity controls.

We also offer modified environments for sensitive products including ultra-low humidity conditions for low moisture requirements, alternate lighting for light sensitivity, and inert gas flushing for oxygen sensitive products.

Inspection Technologies

Ensuring the integrity of trial materials is paramount. We offer the best in inspection

technologies to maintain the highest levels of product safety.
Sophisticated on-line camera systems inspect for correctness throughout the packaging and labeling process, ensuring accuracy in every package produced. Inspection systems confirm presence and correctness of drug product, as well as all study materials.

In addition, inspection systems ensure accuracy of print application for all variable information including batch information, product dating, as well as randomization. Label inspection systems provide assurance that every label produced is verified against customer approved proofs and randomization lists. All systems are extensively validated, as well as rigorously maintained and challenged.

 

 

Primary packaging technologies include:

We offer discreet over-encapsulation technologies to ensure study integrity and appropriate product blinding. Placebo capsule filling as well as filling of drug in capsule/vial product using Xcelodose® technology for both potent and non-potent molecules to support the needs of early stage trials. Verification of product contents ensures each capsule meets the stringent requirements for product delivery.
We feature several form-fill-seal platforms capable of supporting thermo-formed and cold-formed (foil-foil) blister packaging. Our lines are equipped with on-line vision inspection to ensure fill accuracy for every cavity including multiple product fills. We also feature deep draw capabilities for secondary blistering.
Bottle fill technologies support both small-scale and large-scale clinical trials. Lines are equipped to handle solid oral doses including tablets, capsules, and softgels as well as precise powder filling. Capabilities include the addition of single or multiple desiccants, cotton or synthetic coil, induction seals, shrink bands, tamper evident banding, as well as single or multi-panel booklet labels.
Pouching applications include both horizontal and vertical form- fill-seal for powders, gels, and oral solids, including four-side seal pouches and stick-pack style sachets. In addition, we offer horizontal overwrapping solutions for both primary and secondary packaging applications.
Small and large-scale tube filling is offered for topical delivery forms, accommodating liquids, gels, creams, and ointments.

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Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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