Dear
Blister Packaging Machine(tablets, soft and hard gelatin capsules) and cartoning machine (for blisters, banks), including replacement parts and associated accessories + appropriate equipment for laboratory development.
Blister machine a Minimum of 75 blisters/min – 1 pcs. The area of the blisters approximately: 210×150 mm. Lifting column for blister machine – 1 pcs. The control scales a Minimum of 75 blisters/min – 1 pcs. The connecting pipeline between the blister and cartoning machine – 1 pcs.
Machine for packaging cartons in a Minimum of 75 cartons/min – 1 pcs. The dimensions of the box about 215x155x100 mm. Folding instructions, placing the instructions in box, open box, tab, product, packing, sizing or the closure.Packaging bottles for tablet without dismantling the feed conveyor, through a separate feeder, or using the rotary table. Equipment weight control for cartoning machine – 1 pcs. Rotary table/equipment supply of bottles for cartoning machine. The equipment shall be designed in accordance with the guidelines of EU GMP current the editorial, by the FDA, the safety standards of the EU and the Russian Federation.
The inclusion is subject to the following:
Manufacture, supply, installation and commissioning of appropriate equipment
FAT/SAT
Documentation for the qualification and all the necessary certificates
Staff training Novamedica LLC (the location of the supplier or at the place of installation)
Consumables for the equipment for 6 months (if applicable)
The bidder is required to propose or offer a solution for maintenance hardware, Troubleshooting, repair, replacement of parts and supply of consumables
(if necessary).
The dimensions of the proposed equipment must conform to the size of production facilities (see the attached diagram). In case of impossibility of compliance with the size of the room, please suggest the corresponding configuration space.
The requirement for the capability object:
Hard gelatin capsules – up to 36 million capsules/year, 10-30 capsules/blister, 1 to 3 blister/box;
Soft gelatin capsules – up to 36 million capsules/year, 10-30 capsules/blister, 1 to 3 blisters/box
Pills to 10.8 million tablets/year, 10-30 tablets/blister, 1 to 3 blisters/box
Conditions in the production room:
Primary packaging: Clean room category D; Temperature 20 ± 2° relative humidity 40-60%;
Noise level – 65 dB (A). Room height to ceiling is 2.8 m, the height from the floor – 3.4 m.
Secondary packaging: Temperature 18 ± 2°C (cold season), 23 ± 2°C (warm season), relative humidity 15-75%;
Noise level – 65 dB (A). Ceiling height – 3.4 m.
Main equipment
Dimensions of blister machine not bigger than
1700x1000x4000 mm HxWxL
Dimensions of cartoning machine not bigger than
1700x1500x4000 mm HxWxL
additional equipment
lifting column for blister line conveyor between blister and cartoning machine
Checkweigher unit for carton line rotary table/bottle feeder for carton line
Functionality
Tablets, Hard gelatine capsules, soft gelatin capsules, pelettes for blister line
Stainless steel frame and surfaces
GMP execution
forming, sealing, coding, unloading, perforating functions for blister line
PLC+HMI
Internal cooling circuit for blister packaging line
toolless execution missing/failed product detection and ejection system for blister and cartoning
forming area approx. 210×150 mm Forming depth approx. 20 мм
Carton dimensions approx. 215x155x100 mm
Leaflet folding, inserting, carton opening, products insertion, emboss, tuck-in or hot melt closure for carton line
Up to 3 loading stations at loading zone for blister line
Bottles cartoning without deinstallation of blister conveyor for carton line
Best Regards,
