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Manufacturing Capabilities

Solid

Contract Capsule Formulation
and Manufacturing

For full-service capsule formulation and manufacturing, turn to Medical Products Laboratories, Inc. (MPL). MPL's manufacturing team offers exceptional quality and value in contract manufacturing of pharmaceutical human and veterinary products, with pharmaceuticals generally falling under the regulatory classifications of ANDA, prescription, or over-the-counter drugs. MPL's pilot and full-scale mixing systems are designed to ensure successful scale-up to commercial-size manufacturing from the R&D batches by replicating the laboratory equipment. Batch sizes are tailored by MPL to match each client's specific needs.

Pharmaceutical Contract Capsule Formulationand Manufacturing

Capsule Formulation and Manufacturing Process

Each capsule manufacturing process begins with the customer order, from which a work order is produced by MPL's production support team. All raw materials are then staged for weighing. Each material is then weighed one at a time with thorough cleaning procedures implemented between all materials to eliminate mix up and cross contamination. HEPA filtration and positive pressure further prevent cross contamination. Accuracy is ensured with continual calibration of balances at regular intervals. USP-grade purified water is produced from dual de-ionized water systems, which are monitored daily for total organic carbon. GMPs are followed and SOPs are in place to ensure manufacturing errors are eliminated, and full traceability of all raw materials used is confirmed, through MPL's enterprise resource planning (ERP) system. These measures work together to ensure the highest possible quality to MPL's capsule manufacturing.

Capsule formulation and manufacturing is generally done in batches ranging from 16 kg to 160 kg. V-blenders with chopping and intensification capabilities perform any mixing required. Granulations are done through MPL's own qualified manufacturing specialists, or performed in house. Sustained-release capsules are made possible with multiple Vector coating pans for a variety of release profiles. Additionally, MPL can fill powder blends into two-part soft gelatin capsules.

Quality Control

Medical Products Laboratories, Inc.' GMP manufacturing suites feature shatter-proof lighting fixtures, FDA-approved washable walls, separate air handling systems, and powder extraction arms, allowing it to handle virtually any raw material blend. Cross contamination is eliminated through a combination of dedicated hazard areas, HEPA filtration, pressurization, and an extensive environmental monitoring program. Every step of the manufacturing process is performed in front of a witness for double verification of adherence to the approved batch record. Generally, the first three lots of capsules produced are validated for process; additional validations are implemented according to a predetermined schedule. Each batch is safely stored in sealed transfer tanks until packaging is ready to be initiated.

Medical Products Laboratories, Inc.' capsule formulation and manufacturing offers exceptional value at competitive prices. Find out for yourself. Submit a New Product Request Form today.