VINAYAK PHARMA TECHNOLOGY

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3 GENERAL DESCRIPTION Vinayak, Glove Leak Tester is designed for testing integrity of gloves and its sealing with glove port used in various applications. The Gloves are leak tested under the pressure between Pa (as per ISO ). Glove leak tester can be used for both positive and negative pressure isolator either at rest or in operation. This system is custom designed to test 4 gloves at a time. The system consists of mobile trolley containing control and display system with storage space to contain plugs for various port sizes. Sr. No. Description Working Pressure with respect to ambient Qty. 1 Glove Leak Tester + VE 01set Remark: 1 set comprises of complete unit and 4 nos plug of specified size. Plugs are customized based on glove port size with inflatable gasket. We will make personal visit to your plant and take necessary dimensions to design port with inflatable gasket suitable for glove port. Page 3

4 TECHNICAL SPECIFICATIONS Glove Integrity Test Unit This system consists of a basic unit and is able to test up to 4 ports at the same time. The unit to test consistency of glove, cuff ring of the glove, sleeve and cuff ring of the sleeve. Therefore all parts and interfaces of the glove port system can be tested in place. The glove integrity test unit is mobile on wheels and can be used on different Isolators. The unit is made of Aluminum profile, the surface is grounded. Whereas the glove PORT CHANGE PARTS is made of Derlin. Purpose The glove tester is designed to test glove/sleeve systems mounted on an isolator. Technical Data Specifications Test pressure Stabilization pressure Inflation time Pressure stabilization time Leak test time Air Pressure Power supply 250 pa (1000 pa initial acceptance test as per ISO ) 250 pa (20% more than leak test pressure) Approx. 60 sec. As per guidelines As per guidelines 4 to 6 bar 230 V / Hz Page 4

5 Description The glove integrity test unit consists of a basic unit with control system. The necessary test pressure for the integrity test is generated inside the gloves. The gloves are closed with test covers. A tube connects the pressure chamber of the integrity tester with the glove and allows the pressure equilibration of the two compartments. If the glove is tight, the air flow created by the pressure equilibration will become zero after a period of time and the glove /sleeve assembly has passed the test. If there is a leakage, a constant flow in the tube will compensate the losses through the hole. The air flow inside the tubes is monitored separately for each glove by flow indicators. The data is registered and can be printed as a test protocol. Glove tester will be having provision for oval types of glove ports of size 200 mm by 300 mm. Monitoring The system is controlled by an HMI (Color touch pad) with a touch screen. This system not only allow an automated test procedure and the input of batch related data, it does also monitor all data occurring during the test. The data can be taken over via USB port (optional at extra cost). The Glove leak tester shall provide the total printout for test for pass or fail of test. (Optional) Test Covers To close the gloves a test cover has to be attached to each glove port. The cover is equipped with a gasket that guarantees a tight connection, as well as the fixation of the port during the test. Page 5

6 DOCUMENTATION DQ/ IQ / OQ GA drawing Operation and Maintenance manual. SPECIFIC REQUIREMENTS IN CLIENT S SCOPE Utility source connections (HEPA FILTERED AIR) and Power supply till Glove Leak Tester Unit. Cleaning utility & control will be on CLIENT S scope, M/s Fabtech will provide the Provision for the same. Interconnecting electrical cable between Main control panels to operating panel. All respective process equipments. Page 6