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 have been inspected by the Japanese Health Authority. There is also a Mutual Recognition Agreement between Canada and the European Union and Australia that allows products to be easily released to those regions.
Manufacturing services and capabilities.
Extensive range of vessels and mixing capabilities.
- Batch sizes ranging from 200-5,000kg
- 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 separate bulk 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) up to 4,000kg
- 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.
- 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
- Trade or sample units
- Sizes ranging from 1g to 15g
- Foil sachets (semi-solids)
- Brand-new, highly versatile bottle-filling line for plastic, glass, and airless bottles
- Six non-sterile 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
- Nasal spray pumps
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. CPL can also support serialization for European markets that comply with the European Union Falsified Medicines Directive.
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.
- Raw materials testing – compendial and non-compendial
- Bulk and finished product release testing
- Residual solvent analysis
- Nasal spray product release testing
- Microbial limit test (MLT)
- Anti-microbial effectiveness test (AET)
- Method validation: suitability test
- USP, EP/BP
- Six walk-in stability chambers at ICH conditions
- Dedicated stability coordinator
- Remote alarm monitoring of chambers with back-up generators
- Reach-in stability chambers
- Photostability chamber and testing
In-vitro release testing (IVRT).
- Release and stability testing per FDA/SUPAC-GMP guidelines
- Product bioequivalence testing
- Method transfers or method development/validation
- Hanson Franz cell instrument housed in the GMP QC lab