All our policies and procedures are based on current Good Manufacturing Practices. All manufacturing facilities are formally audited for cGMP requirements twice annually. Our methods of manufacturing are outlined in our Bottle Drug Master File, #1933 and our Closure Drug Master File, #12877. Our production department follows, without deviation, our approved procedures.
Drug Plastics prides itself on being a full-service plastic packaging supplier with technical expertise in all disciplines of container molding processes. We offer our customers bottles and specialty closure systems made via:
Drug Plastics Mold Company consists of journeymen mold makers and dedicated mold maintenance personnel. Our capabilities include extrusion blow molds, injection blow molds, injection molds, blow stations for PET molds and core rod manufacturing as well as repair and maintenance of all sorts of molds.
Drug Plastics repairs and maintains 100% of our molds. Along with using conventional machining equipment, the Mold Company employs the latest modern technology: CNC milling and turning centers, micro and TIG welding, and ultrasonic mold cleaning.
Drug Plastics Product Development Group uses computer-aided designs in all our engineering and drafting activities. Experienced engineers and designers typically work on product drawings and mold designs, automation, mold specification and procurement. Capabilities are enhanced by employing CAD design and 3-D solid modeling for rapid prototyping (stereo-lithography).
The design of a package is optimized by engineering the most perfect seal with custom or stock closures. Tooling lead times are minimized by using e-mail for drawing transfers. Models can be built in less than one week, and production molds are designed and manufactured in as little as four weeks. Response to a customer inquiry of a technical nature is two days under normal circumstances and overnight in urgent situations.
The Sampling Group is staffed with highly experienced molding technicians led by a Chief Process Engineer. This group is responsible for establishing optimal mold processing parameters as well as for training of process and set-up personnel in Drug Plastics plants.
Drug Plastics uses only FDA-approved raw materials for all molding applications. Our own Certification Programs insure an uninterrupted source of materials from certified suppliers at the lowest possible cost.
Our cGMP manufacturing environment and adherence to carefully developed procedures assure our customers 100% lot traceability. In addition, our label reconciliation program provides case traceability - enabling us to identify the date and time of manufacture of each carton. This information is kept on file in the Quality Department with the rest of the job history for future review and analysis.
COMPUTER INTEGRATED MANUFACTURING
CIM is a state-of-the-art, real-time production and process monitoring system, which provides direct integration of customer orders and specifications as well as on-line correlation of product measurements and discrete process information. Drug Plastics dedicated team of technicians use statistical techniques to control more than 20 process variables on machines processing HDPE, LDPE and PP bottles and more than 50 process variables on machines processing PET bottles in order to ensure our customers that we manufacture consistent uniform quality.
Additionally, as a routine part of our Production Reconciliation Program, we run full pareto analysis of rejects, down time and assist calls in order to reduce variation and improve production efficiencies. This system is also equipped to provide a variety of automated charts, graphs and reports either routinely or on demand.