Patient Safety

Plastic, Polymer and glass packaging for pharmaceutical packaging is critical for patient safety, drug efficacy and consumer performance. It's also important to understand how choosing the correct material or configuration impacts costs and even sustainability.

FCP has worked with the FDA, USP, EU and JPN to support global regulatory requirements.

With our extensive knowledge and experience in both primary and secondary packaging, our organization, FCP, has successfully assisted customers for many years not only in selecting the right materials for their packages but also in organizing their supply chains to fulfill highly specific and demanding requirements.

Let us help.

Understanding The Technical Challenges....

Glass as a primary container:

· Container selection process and support

· Supplier selection and sourcing review

· Qualitative aspects and how these impact your process

· AQL and KPI review for optimal output

· Shelf-life

· Container design

· Liquid, powder and lyophilization review and support

· Cost review and cost modeling based on your process

· Type I borosilicate glass versus other glass packaging options

· Container and drug interaction review

· L&E study support

· Glass tubing as a base material

· Syringe review and options

· Syringe production and supplier analysis

· Cartridge design

· Special coatings for glass for increased silicate structure

· Glass Delamination support and root cause review

· Production and set up support

· OEE and KPI troubleshooting

· Parenteral and CMO filling support

Blister Packging

• Material Selections and Options:films & Foils

• Laminated Films

• Coated Films

• Card & Package Designs

• Tooling and forming machines

• Sustainability & circularity impacts; PFAS, PVC, etc.

• Supplier review & analysis

• Barrier alignment for optimized shelf life

• Assessment and technical services

• Packaging support and guidance

• CMO options

• Production machine guidance

• IR,OTR, MVTR and UV studies

• Compliance advice & guidance

• Process & product optimization

Plastic Bottle & Closure:

• Design & material selection

• Time, temperature & environmental aspects to stability

• Reuse, recycle and sustainability guidance

• Barrier assessment and alignment

• Light weighting and package optimization per FDA QbD design

• Shelf life and critical failure assessment

• Liner & tamper evidence review

• Child resistance testing and compliance support

• Closure options

• Supplier & sourcing review

Our Services

Expert packaging solutions tailored for pharmaceutical success.

Prototype Design

Custom blister and bottle designs ensuring optimal drug protection.

Child Resistant

Safety-focused packaging to prevent accidental access by children.

Component Sourcing

Access to top-quality glass, syringes, stoppers, and more.

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