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Validates PIAB's New Vacuum Conveyor System

Stoughton, MA (July 30, 2003) -- Biomatic is pleased to announce the protocol development and successful IQ, OQ, PQ validation of two new and unique vacuum conveyor systems at PIAB USA in Hingham, Massachusetts (www.piab.com/us). PIABs new line of vacuum conveyors offers a unique system to transfer raw or finished products, including food and pharmaceuticals. PIAB's C-Series vacuum conveyors was developed with one aim: To raise productivity, while conveying material even more efficiently. PIAB manufactures CE marked vacuum conveyors that fulfill the requirements of the USDAs (United States Department of Agriculture) stringent standards regarding hygienic equipment used for the production of pharmaceutical products, dairy products and food products. The new C21 and C33 Series Vacuum Conveyors are made of acid-proof stainless steel (Grade AISI 316L) to meet the hygienic requirements of food and pharmaceutical industries. All materials included in the conveyors meet the requirements of the FDA (Food and Drug Administration). Protocol Developed Biomatic and PIAB USA technical staff collaborated to develop the IQ, OQ, PQ protocol for validation of the C21 and C33 Series Vacuum Conveyers. Upon approval of the protocols, the OQ/PQ validation was performed under real-world conditions. PIABs revolutionary conveyor system starts by generating a vacuum via a PIAB vacuum pump (A), which is driven by compressed air. With the closing of a valve (B), the vacuum is raised in an interior container (C) as well as the conveying pipeline (D) and the material is drawn from the feed station (E) into the conveying pipeline and then into the interior container. A filter (F) prevents dust and fine particles from being drawn into the pump and escaping into the surroundings. During the suction period, air shock tanks (G) are filled with compressed air. When the interior material container is full, the vacuum pump stops. The bottom valve then opens and the material in the interior container is discharged. At the same time, the compressed air in the filter tank is released and cleans the filter. When the pump is restarted, the process is repeated and a new cycle begins. The suction and discharge times are normally controlled by pneumatic or electrical control systems (H). The validation protocols included the measurement and verification of pressure, vacuum, and sound for each cycle using NIST traceable devices and the proper transfer of materials from feed station to final destination. In addition, temperature and humidity levels of the testing environment were recorded for future reference. Qualification Steps The IQ (Installation Qualification) for the vacuum conveyor systems included recording the model and serial number, manuals and other documentation, proper

installation and platform, inspection of regulators and gas pressure, and proper grounding of the units and feed containers. The OQ (Operation Qualification) included verification of the operation sequence, such as system startup, flow of gas into the system, valve closing and vacuum generation, valve opening and release of products, air shock activation to clean the filters, start of gas flow, and repeat of sequence. The PQ (Performance Qualification) for the C33 Vacuum Conveyor system included the transfer of rice grains through a 2-inch diameter by 37-foot PVC tubing with a vertical lift of 11 feet. About 45 lbs. of rice was re-circulated for a period of 4 hours (250 cycles). Approximately 0.45 cubic feet of rice (about 20 Lbs) was transferred in each cycle, corresponding to about 110 cubic feet in 4 hours. No malfunctioning of the system during the execution of the OQ/PQ was observed. The system is capable of transferring bulk materials of several tons per day, all automatically. The IQ, OQ, PQ validation of the C21 Vacuum Conveyor is similar to the C33 except the unit included a PLC controller (programmable logic controller) for operating the unit and a lower transfer capacity (0.12 cubic feet per cycle). PIAB's new vacuum conveying system is completely enclosed, hygienic and safe, making it ideal for food and pharmaceutical industries, which demand an extremely high degree of hygiene and safety in transferring ingredients and finished products. Powders and granules are ideal for vacuum conveying and a great number of materials, even those that are health impairing and/or sensitive to humidity and contamination, can be safely conveyed.