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Through the use of stringent controls of aseptic conditions as well as highly trained production operators, we have established ourselves as a leading global provider of aseptic topical products.
Sterile semi-solid manufacturing
We have an excellent track record of sterility assurance and US FDA compliance for the manufacturing of ointments, creams and gels.
- Tube sterilization through gamma irradiation and in-coming tube logistics are managed by Cambrex personnel using validated methods, qualified protocols and vendors
- All compounding is carried out in a class C area
- Aseptic 0.22 um filtration or in-situ steam sterilization are offered
- Production can utilize glove ports for the transfer of sterile API via an aseptic transfer vessel
- Components are filled under Class A conditions
- Labelling and cartoning services are also offered
We perform aseptic media fills and operator qualifications on a frequent basis and produce approximately 1 million tubes each year. At Cambrex, we offer a full range of microbiology and analytical QC services in support of the production of sterile semi-solids.
Suite capabilities
Our sterile semi-solid suite is fitted with a Krieger 600 MMD batch processor that can handle batch sizes ranging from 200 kg to 450 kg.
In addition, we have an IWKA TF 20 robotic tube filler to minimize human contact in the tube filling process. The suite is capable of filling tubes ranging from 3.5 g up to 100 g of ointments, creams or gels. The suite can manufacture bulk up to 200,000 kg annually.
Non-sterile semi-solid manufacturing
We have an excellent track record of US FDA and Health Canada compliance including the manufacturing of ointments, creams and gels for all types of topical compounds:
- Pilot, clinical trial material and commercial-scale manufacturing
- Segregated manufacturing suites
- Semi-solid cGMP batch sizes from 25 kg to 1000 kg
- Vacuum deaeration
- Labelling and cartoning services are also offered
We can produce up to 325,000 kg of bulk topicals and offer a full range of microbiology and analytical QC services in support of the production of non-sterile semi-solids.
Suite capabilities
Our non-sterile semi-solid suites are fitted with a development and pilot scale Ekato Unimix SRC-150 that can handle batch sizes ranging from 25 kg to 150 kg. The Ekato is equipped with state-of-the-art vacuum de-aeration and can handle viscous polymers.
In addition, our production scale equipment can handle batch sizes up to 1,000L. Our tube filling equipment includes a Romaco Unipac U 20100 automatic tube filler capable of filling laminate, plastic, aluminum tubes at high speed. Our tube filler is capable of filling tubes ranging from 2 g up to 240 g of ointments, creams or gels.
Suppositories
At Cambrex, we have development and production scale suppository filling machines at our Whippany and Mirabel facilities. Between both of the sites we can produce over 100 million units annually.