Semi-Solid
Semi-Solid Dosage Forms
Contract Manufacturing
Medical Products Laboratories, Inc. (MPL) provides full-service pharmaceutical contract manufacturing and packaging of semi-solid dosage forms, including foams, gels, pastes, shampoos, ointments, creams, cleansers, and lotions. These semi-solid dosage forms are generally produced under regulatory classifications as drugs (ANDA, prescription, and OTC), medical devices, or cosmetics. From lab scale-up and pilot batch, to full commercial production, MPL plays an integral role in the development of both human and veterinary products. MPL tailors its batch sizes for the specific needs of each of its clients, whether small or large.
Raw materials are secured by MPL's in-house purchasing team, which are then tested to meet the specifications approved by MPL's Quality Control team prior to release for use in manufacturing. MPL replicates all laboratory requirements established during research and development with its pilot and full-scale mixing systems to ensure successful scale-up from R&D lab batches.
Manufacturing of Semi-Solid Dosage Forms
Upon receipt of a customer order, MPL’s product support team generates a work order and stages the raw materials for weighing. Weighing suites feature HEPA filtration and positive pressure to prevent cross contamination. Only one raw material is weighed at a time and cleaning procedures are performed after each raw material is weighed to prevent mix up or cross contamination. All balances are regularly calibrated to ensure accuracy. Purified water is often the most used raw material. MPL's dual de-ionized water systems, which produces USP-grade purified water is monitored daily for total organic carbon. MPL’s enterprise resource planning (ERP) system allows for traceability of all raw materials used, and our process is designed to ensure the highest level of quality is achieved during the manufacturing process of all products, including gels, lotions, creams, foams, pastes, ointments, and shampoos.
Batch sizes of gels, creams, foams, pastes, lotions, and ointments typically range from 100 kg to 1,000 kg. Stainless steel tanks are generally used for mixing; these can be jacketed for heating processes that may be needed. Inline chillers are used for those products which require rapid cooling. Overhead, high sheer, homogenization, recirculation, sweeps, inline powder dispersion, and planetary mixers are all included among MPL's extensive mixing systems for the manufacturing of semi-solid dosage forms. MPL's in-house design and maintenance department can even fabricate custom manufacturing equipment to fit current and future client needs.
Quality Control
MPL's Quality Control is second to none. Each of MPL's manufacturing suites is designed for a specific mixing system. With separate air handling systems, powder extraction arms, shatter-proof lighting fixtures, and FDA-approved washable walls, Medical Products Laboratories, Inc. is equipped to handle virtually any raw material blend. Extensive environmental monitoring, dedicated areas for more hazardous products like corticosteroids, and pressurized and HEPA-filtered GMP manufacturing suites ensure there is zero cross contamination. Each step of the manufacturing process is performed and witnessed for double verification to ensure adherence to the latest version of the approved batch record. MPL's on-site Quality Control lab allows for fast adjustments of formulations. Generally, the first three lots produced are subject to process validations, with subsequent validations performed according to schedule. Transfer tanks hold the finished gels, creams, ointments, shampoos, pastes, and foams until the commencement of packaging.
Medical Products Laboratories, Inc. provides the highest value in contract manufacturing of pharmaceutical, human, and veterinary drug products, as well as cosmetic creams, foams, gels, ointments, shampoos, and pastes. Find out for yourself. Let MPL know about your specific semi-solid contract manufacturing requirements by submitting a New Product Request Form today.