Commercial manufacturing

Lean manufacturing principles designed to meet various product needs

We are a global leader in the non-sterile liquid and semi-solid market. We’ve earned this position by forming an outstanding, experienced manufacturing team, investing in cutting edge equipment and facilities, prioritizing product quality, and keeping the customer top-of-mind at each and every stage of the process. We employ lean manufacturing principles, which our clients experience via reduced lead times.

 

Our facilities are registered with the U.S. FDA, Health Canada, and the Japanese Health Authority.

Manufacturing services and capabilities.

Extensive range of vessels and mixing capabilities.

  • Batch sizes ranging from 400Kg to 5,000Kg
  • Various mixers, homogenizers, and scrapers
  • Steam-heated and water-cooled jackets
  • State-of-the-art twin XP-rated Symex mixing vessels (1,000Kg and 2,000Kg)

 

Eight dedicated commercial manufacturing suites.

  • Segregated suites for hormones
  • Separate suite for pilot and scale-up batches (20Kg to 300Kg)
  • Two explosion-proof suites for flammable (alcohol-based) formulas (Class I, Div I)

Specialized equipment.

  • Nitrogen blanketing for oxygen-sensitive products
  • Yellow-lighting for light-sensitive materials
  • Vacuum/de-aeration equipment

Filling and packaging services and capabilities.

Whether you’re starting from scratch with a brand-new product or trying to improve on an existing drug delivery system, CPL offers flexible filling and varied packaging solutions to meet your product requirements.

Tubes.

  • Five tube-filling lines supporting metal, plastic, and laminate tubes
  • New IWK XP tube-filling and secondary packaging line (aluminum and plastic tubes)
  • Sizes ranging from 2g to 250g
  • Nitrogen blanketing

 

Sachets.

  • Trade or sample units
  • Sizes ranging from 1g to 15g
  • Foil and stick packs

Bottles.

  • Brand-new, highly versatile bottle-filling line for plastic, glass, and airless bottles
  • Six liquid lines – plastic- and glass-type bottles
  • Sizes ranging from 15ml to 400ml (non-XP) and 5ml to 250ml (XP)
  • Metered-dose and airless pumps, CRC caps and closure systems
  • Tamper-evident seals and shrink wrapping
  • Nitrogen blanketing

Secondary packaging.

  • Cartons
  • Inserts

Product serialization standards.

We are serialization-ready, in compliance with the Drug Quality Security Act (DQSA). Though compliance was not mandatory until November 2017, we have been ahead of the curve to ensure our products are traceable according to FDA standards.

 

Additionally, we have invested in a serialization strategy of both software and hardware systems to support our partners’ serialization requirements with an ongoing strategy for aggregation as new traceability laws take effect.

Testing services and capabilities.

Our GMP lab operations provide a complete range of testing services, from research and development to routine analytical testing, microbiological testing, and stability program management – all within our U.S. FDA and Health Canada approved establishments.

Analytical testing.

  • Raw materials testing – compendial and non-compendial
  • Bulk and finished product release testing
  • Residual solvent analysis

 

Microbiological testing.

  • Microbial limit test (MLT)
  • Anti-microbial effectiveness test (AET)
  • Method validation: suitability test
  • USP, EP/BP

Stability management.

  • Six walk-in stability chambers at ICH conditions
  • Dedicated stability coordinator
  • Remote alarm monitoring of chambers with back-up generators

 

In-vitro release testing (IVRT).

  • Release and stability testing per FDA/SUPAC-GMP guidelines
  • Product bioequivalence testing
  • Method transfers or method development/validation
  • Testing of topical formulations including gels, creams, lotions, and sprays
  • Hanson Franz cell instrument housed in the GMP QC lab

Ready to get started on your project?