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Pharmaceutical and Veterinary Tablets
Medical Products Laboratories, Inc. (MPL) is a full-service contract manufacturer and packager of pharmaceutical tablets for both human and veterinary products. From lab scale-up and pilot batch to commercial production, MPL's manufacturing team plays an integral role in manufacturing pharmaceuticals, veterinary products, and cosmetics. Pharmaceutical tablets manufactured by MPL generally fall under the regulatory classifications of ANDA, prescription, or over-the-counter drugs. MPL also manufactures veterinary tablets. Batch sizes are tailored for each client's needs, and MPL's pilot and full-scale mixing systems are designed to replicate laboratory equipment to ensure successful scale-up to commercial-size manufacturing from the R&D batches.
Pharmaceutical Tablet Contract Manufacturing
First, MPL's product support team creates a work order. Then MPL's in-house purchasing team secures all raw materials, and the Quality Control team ensures all materials meet approved specifications. Mix-up and cross contamination is prevented by weighing only one raw material at a time. Cleaning materials are performed in between each weighing of raw materials, and all balances are calibrated at defined intervals to ensure accuracy. MPL is equipped with dual de-ionized water systems that produce USP-grade purified water. MPL monitors the water produced daily for total organic carbon to ensure purity. Traceability of all raw materials is ensured by MPL's enterprise resource planning (ERP) system. MPL's process for manufacturing pharmaceuticals for both human and veterinary products ensures the highest potential level of quality available from tablet manufacturers. Whether manufacturing chewable, enteric, or film-coated tablets, MPL has the blending and compression expertise to develop and produce your products.
Batch sizes for pharmaceutical tablet manufacturing typically range from 16 to 160 kg. V-blenders are typically used for mixing; intensification and chopping capabilities are available if needed. MPL performs granulations in house, or processes them with a qualified manufacturing specialist. Single or double station B&D tooling sized compression machines with pre-compression capability can be used depending on the desired size and shape of your tablet. Tablets can be coated with a variety of film coatings using MPL’s multiple vector coating pans.
Quality Control
With FDA-approved washable walls, separate air handling systems, shatter-proof lighting fixtures, and powder extraction arms in its manufacturing suites, Medical Products Laboratories, Inc. can handle virtually any blend of raw materials. Cross contamination of all kinds is prevented by a long list of Quality Control measures, including pressurization, HEPA filtration, dedicated hazard areas, and an extensive environmental monitoring program. MPL's Quality Control laboratory allows for fast in-process testing. The manufacturing process is performed step by step according to the approved batch record, with each step witnessed for double verification. Process validation is generally mandated for the first three lots of pharmaceutical and veterinary tablets produced, with additional validations administered according to a predetermined schedule. Transfer tanks then store each batch until the packaging process ensues.
MPL delivers consistently high quality pharmaceutical human and veterinary tablet contract manufacturing at highly competitive prices. Choose Medical Products Laboratories, Inc. for your contract manufacturing needs. Submit a New Product Request Form today.