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FOUNDED in 1972 and employing more than 100 people, Vector Corporation of Marion, Iowa, manufactures production equipment for processing solid dosage/form materials for the pharmaceutical, health care, chemical, food, confectionery and pyrotechnics industries. Included in the product lines are tablet coating machines, fluid bed granulator/coater/dryers, high shear granulators, roller compactors, tablet presses and automated process control systems. Primary distribution markets are North and South America and Europe, with an increasing emphasis on other continents, making Vector a global company.
Batch Systems Control the Process
There are two types of tablet coating systems: continuous and batch. Though not the company’s standard product line, continuous coating systems typically produce very large volumes per run and use shorter coating times per volume. Typical applications for continuous coaters include OTC medicines and vitamin products. Batch systems are usually employed for all prescription products, and can also be used for OTC products and vitamins. Batch systems generally provide better control of coating quality, uniformity and efficiency. They also provide batch documentation, allow process development and scale-up, and have minimal product loss.
Vector’s batch-based tablet coating systems include a standalone coating machine, plus several peripherals (such as driers and filters) to supply correct amounts of air at the right temperature, humidity and pressure. Available in varying capacities, these systems use a Windows XP Professional-based host computer to supervise every step of each batch process, which includes monitoring up to 200 I/O points every 10 seconds. For most pharma applications, FDA regulations require a clean-in-place (CIP) skid. To meet U.S. Food and Drug Administration (FDA) 21 CFR Part 11 electronic recordkeeping rules, the Compu 4, ISA S-88 based control system uses both custom batch software and off-the-shelf SCADA software, and is considered a 21 CFR Part 11 “Closed System.” A closed system is defined as “an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.” This includes not only batch records but also the underlying Windows XP Professional operating system.
While a small PLC, such as the Rockwell SLC 5/05 Series, is used to control the coating machine’s speed, air flow, temperature, humidity, pressure and other process variables, an industrial computer supervises the PLC, associated peripheral systems, and the CIP system.
|MEETING 21 CFR PART 11 SPECS|
Vector’s Model VPC1355 batch tablet coater uses a 21-in. NEMA 4X CCS industrial computer with a RAID 1 hard disk system.
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