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-TD-02 Doc. No. NPI-120310-EQP-S1-TD-02 Revision : 00 Date : 2014.03.11 1/92 TENDER DOCUMENT FOR SUPPLY, INSTALLATION, COMMISSIONING & VALIDATION OF VIAL WASHING MACHINE WITH DEPYROGENATING TUNNEL AND VIAL SEALING MACHINES Client : Project No : 120310 DOCUMENT NO : NPI-120310-EQP-S1-TD-02 Revision : 00 Date : 2014.03.11 TENDER DOCUMENT FOR SUPPLY, INSTALLATION, COMMISSIONING AND VALIDATION OF VIAL WASHING MACHINE WITH DEPYROGENATING TUNNEL AND VIAL SEALING MACHINES AT HLL BIOTECH LIMI.
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Vial washing machine validation guidelines FAQ
Acceptance Criteria: Sodium chloride content should be absent in any of the spiked vial. Vials should be free from foreign particle & fibers on visual inspection. 10µ particles should not be more than 25 and 25µ particles should not be more than 3. Vials should comply endotoxin limit i.e 0.25 EU/vial.
Working Principle of Rotary Vial Washer Vials feed from the Infeed turn table / tray are received on Infeed Starwheel / Feedworm then moves on Infeed starwheel. The Grippers picks up the vial from Infeed Star Wheel and invert it in neck down position over washing needles and move along with the needle bar for Washing.
Acceptance Criteria: Sodium chloride content should be absent in any of the spiked vial. Vials should be free from foreign particle & fibers on visual inspection. 10µ particles should not be more than 25 and 25µ particles should not be more than 3. Vials should comply endotoxin limit i.e 0.25 EU/vial.
Working Principle of Rotary Vial Washer Vials feed from the Infeed turn table / tray are received on Infeed Starwheel / Feedworm then moves on Infeed starwheel. The Grippers picks up the vial from Infeed Star Wheel and invert it in neck down position over washing needles and move along with the needle bar for Washing.
Utilities of Vial Washer Machine Pneumatic Air: Filtered, oil free, sterile low-pressure Air at 5kg/cm (4/6 bar) 150 CFM.
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