A closer look at Mayne Pharma’s new commercial manufacturing equipment
When outfitting its new commercial manufacturing facility, Mayne Pharma invested in some of the highest quality pharmaceutical equipment available today. Pieces have been carefully selected to complement existing platforms, minimize scale-up risks, and expand capabilities. On behalf of Mayne Pharma, its parent company, Metrics Contract Services is pleased to provide this closer look at some key pieces being added to the new commercial facility.
Glatt VG Pro 440 high-shear mixer for wet granulation + solvent-capable Glatt GPCG Pro 120 fluid-bed dryer with Wurster coater
Glatt is a well-recognized supplier of integrated process solutions for the global pharmaceutical industry. New Glatt equipment was selected to create a scalable path to commercialization that starts with Metrics’ existing GPCG 1 for non-GMP development. A smaller-scale GPCG 10 with high-shear granulator and Wurster processing was added in 2017 for clinical manufacturing. A GPCG 30 has been acquired and will be installed and qualified in 2018. Important features of the Glatt fluid-bed system being installed in the new commercial facility include:
- Adaptability – Wurster process allows coating of beads or pellets for modified-release products with pulsed, delayed or sustained release profiles. The equipment and facility support both aqueous and organic solutions.
- Flexibility – a wide range of batch sizes can be supported. Wurster processing capacity is 100-250kg per batch and fluid-bed drying capacity is 80-265kg per batch.
- Capability – coating can be used to mask unpleasant taste or odor, improve stability, or enhance patient compliance through less frequent dosing.
- Compliance – the integrated high-shear granulation and fluid-bed drying can aid in containment, reduce transfer losses, and decrease processing time. The automated clean-in-place design is efficient and mitigates cross-contamination concerns.
IMA Adapta 100 high-speed capsule filler with 100-percent inline weight checking
IMA has produced high-tech automated capsule-filling machines for the international pharmaceutical industry for more than 50 years. The IMA Adapta 100 was selected with scalability in mind to complement the new IMA Zanasi 16E Plus capsule filler that Metrics is installing in the pre-commercial facility in 2018. Important features of the IMA Adapta 100 capsule-filling system for the new commercial building include:
- Versatility — reversible and interchangeable dosing stations suitable for powders, pellets, and beads.
- Adaptability — combinations of powders, pellets or beads can be filled into the same capsule.
- Compliance — in-process control with individual capsule weight checking for accuracy.
- Flexibility — filling speeds up to 100,000 capsules per hour.
Thomas Flex 500 Perforated Pan Coater
The Thomas Flex 500® production-scale pan coater was selected for its ability to cover a wide range of capacities. Important features of the coating system in the new commercial facility include:
- Flexibility — interchangeable 48-inch to 65-inch drums support a range of lot sizes and can reduce cycle times.
- Versatility — the facility and coating equipment can support film, sugar, functional and drug-layering of aqueous and solvent coatings.
- Compliance— cabinet design aids in containment and cleaning.
Packaging line: New Jersey Machine packaging line with IMA automated case packer and palletizer
NJM offers both stand-alone solutions and integrated systems for packagers of solid-dose pharmaceuticals worldwide. The new commercial packaging line will be the third bottling line at Mayne Pharma’s Greenville site with one line in the pre-commercial building and two lines in the new commercial building. Both commercial bottling lines will be fully serialized and aggregation capable in 2018. The new NJM packaging line includes a four-head Cremer filler, a Palace desiccant feeder and Enercon induction sealer. Important features of the new packaging line and automated palletizer in the commercial manufacturing facility include:
- Versatility — four counting modules that fill up to 120 bottles per minute (based on 60-count bottles). The number of counting modules can be modified as production needs change.
- Accuracy — a wide variety of dosages and containers can be filled with accurate counting at high speeds, increasing productivity and efficiency.
- Flexibility — the line can fill coated and uncoated tablets from 3mm to 30mm in length and from 6mm to 20mm in diameter into round, oval and rectangular bottles made of glass or plastic ranging from 40mm to 200mm high and 20mm to 125mm in diameter.
- Compliance — the packaging line supports full serialization compliance with aggregation using an Optel solution for the lines and site and including a TrackSafe vision system. Mayne Pharma is using TraceLink as its Level 4 provider.
- Efficiency — the IMA automated case packer and palletizer allows continuous flow of bottled product through bundling / wrapping, case packing, and palletizing at speeds that align with the bottle-filling operation.
Want to learn more about our new 126,000-square-foot facility? Watch a short video about the building.