AAZ Business Solution

S.No Item Description Qty 1 Freeze Dryer/ Lyophilizer Total usage area 2.6 m2+ 10%. All product contact part 316 L, Stainless steel meeting GMP standards. Shelf clearance minimum 3 to 4 inches adjustable. Shelf temperature range -55 oC to 60o C. Stoppering system automatic. Condenser maximum low temperature <-75 oC. Cooling system double stage Compressor Copeland/equivalent. Vacuum two stage rotary pump EDWARD/equivalent. Vacuum break system with inert gas through 0.2 micro filter and all other safety protection factors be included. Final vacuum less than 0.01m.bar to .001m.bar. Systems include SIP and CIP. Temperature sensor location at thermal fluid, shelves, condenser and product. The design should be in accordance with the GMP requirements. Set of product loading trays (26 to 28 No,s) made of 316 L stainless steel adjustable to the shelves. Visualization system included. Provision of remote computer system to control Lyophilisation Cycles. The cooling system for compressor should be air cooled. The IQ, OQ and PQ will have to be qualified. Electrical rating 380/440 Volts AC, 3 Phase, 60 Hz. All gauges and meters to be calibration certificates. Installation with training at factory and on site to be provided by the supplier. FAT and SAT included. After sale service and running spares for one year which should include one door gasket, one se of Filter dryer, and other critical spare parts. Guaranty/Warranty for one year. Instrument drawing including all electrical and mechanical to be provided along with the machine. Also guaranty for the availability of the spares of at least 10 years to be provided. Any transportation or installation damages to be borne by the supplier installation and commissioning included. Make: Imported (Japan, USA / Europe/equivalent with same specification, capacity and quality). 1 2 Autoclave Horizontal: Single door steam operated. Fully automatic with PLC control, with Data Logger/Printer having multi probes, multi channel temperature recorder & printer along with multi probes/sensors/Thermocouples. (min 03 probes) Automatic cycle phases pre vacuum, sterilization, exhaust, drying, cooling etc) also the program should include both Wet as well as dry sterilization. With the option of self steam generation system (Separate price may be quoted for this option if attached separately). Chamber size: 914x1219x1400 (H x W x D) mm+- 10% Variation in dimension (50-55 cuft) 1550 Liters Approximately). Material Of construction: Chamber Material Stainless Steel 316L, Power requirements: 230VAC, Phase single or 440/380VAC, Three Phase 50/60Hz. Accessories: With one loading trolley and all other accessories/running spares of the equipment for one year, including door gasket, one set of thermocouples and one bio-seal. The IQ, OQ & PQ certification will have to be qualified. 3years guarantee. 1 3 Autoclave Horizontal: General Specifications: Double door (Pass through) (one on either side) Steam operated. Fully automatic with PLC control. With data logger/Printer having multi probes, multi channel temperature recorder & printer along with multi probes/sensors/min 03 probes thermocouples. Automatic cycle phases (Pre Vacuum, Sterilization, exhaust, drying cooling etc)/ Also the program should include both wet as well as dry sterilization With provision to hook with computer/ Should meet all cGMP requirements with option of self steam generation system (Separate price may be quoted for this option if attached separately). Chamber size 914x1219x1400 (HxWxD)mm+-10% VARIATION IN DIMENSION (50-55CUFT )(1550LITER APPROXIMATELY Material of Construction: Chamber material Stainless Steel 316L Power Requirements: 230VAC, Phase Single or 440/380VAC, Three Phase 50/60Hz Accessories: With loading trolleys, quantity 02 each *one on either side) and other accessories/running spares of the equipments for one year, including door gasket, one set of thermocouples and one bio-seal The IQ, OQ & PQ certification will have to be qualified. 3years guarantee. 2 4 Hot Air Oven (Class 10); General Specifications: Single door Fully automatic with microprocessor controller and provision of Data Logger/Printer. Having Multi probes multi channel Temperature (03 probes min) recorder & Printer along with multi probes/sensors/ Provision to hook with computer with door lock alarm. Should meet all cGMP requirements. Temperature thermostat range up to 300oC Materials of Construction & Size Internal dimension 914 x914 x 1219 (H x W x D) mm+-10% variation in dimension (35-36 cuft/ 991-1020 liters approximately). Minimum six shelves. All contact parts of internal chamber made up to stainless steel-314L and outer material 304L (As per cGMP) requirements. Power requirements: 220x240volts AC, 50/60Hz, Three phases. Comprehensive Services and Qualification: The IQ, OQ & PQ certification will have to be qualified calibration & Validation will be the responsibility of Suppliers with

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