Cartoning Machine enquiry from Serbia

Request for proposal bids for cartoning machine

Our company involved in dietary supplement, common goods’ and medical devices manufacturing. For the year 2017. manufacturing of medicines is also planned. Manufacturing and storage facilities are located in Slobodna zona, Belgrade.
For automization of secondary packaging process for semi-products (into secondary packaging), our company requires cartoning machine with following characteristics:
Cartoning machine with be set out on the first floor of the manufacturing location mentioned above.
Cartoning machine use is intended for packaging of the following product:
. Blister cards
. Bottles, glass 125 ml and 250 ml (syrups)
. PE/PET containers, volumes: 20, 30 and 100 ml (sprays)
. Powder sachets (ranging from 1 to 20 g in weight)
Bottle and sachet placement onto the bucket conveyor is done manually.
General requests
Cartoning machine must be automatic and have a possibility for packing 1, 2 and 3 blister cards with capacity of 200 cartons/minute
Carton sizes for blister packaging are:
Carton containing one blister card: 116 x 75 x 17 mm
Carton containing two blister cards: 118 x 82 x 22 mm
Carton containing three blister cards: 130 x 80 x 30 mm
All the appropriate supporting documentation is requested, work operation manual and other reference documents in concordance to GMP regulations.
Main and other machine parts
It is necessary that the cartoning machine is in line and connected procedurally to the blister machine. Other semi products are placed manually onto the cartoning machine (glass bottles, PE/PET containers, powder sachets).
Optionally, Patient information leaflet (PIL) folding machine is also welcome. Cartoning Machine must have ink-jet printer installed, with options for writing in minimum of three separate rows.
Control segments
It is necessary that the cartoning machine has the following controlling characteristics:
Product placement control
PIL placement control
Number of blisters per pack control
EAN code placement on carton and instructions control
Print control (on carton)
Protection during machine work
Safety system must be able to automatically stop cartoning machine processes if irregular machine work is experienced.
Electro-protection system must stop cartoning machine process if work irregularity occurs.
Work display
An appropriate display showing work parameters and providing dials for cartoning machine control is desired.
Installation needed
For cartoning machine optimal function a continual electric current input and potentially, fluid supply (compresed air, demineralised water…) must be indicated.
Supplier must provide training services regarding maintenance and cartoning machine operation that do not require official service engagement.
Installed equipment starting from instalment and verification completion must have 2 year warranty.
Warranty must cover in place assessment and repair services in case of component manufacturing has suffered a factory error.
Service provider must inform performance effective changes within warranty period.
Service provider must inform us on any cases of product recall due to hidden defects or safety issues within the machine.
Maintenance outside of warranty
Cartoning machine supplier must provide maintenance services in both warranty period and after. Reaction time for services will be defined in the contract. Service provider must also provide spare parts in accordance to defined criteria in case of cartoning machine malfunction.
Cartoning machine commissioning
Commissioning during handover implies:
Electric installation check
Cartoning machine work verification.
Control parameter verification
Display performance verification
Cartoning machine qualification process
Installation and operational equipment qualification is required (IQ, OQ).
Performance qualification is required, in agreement with the service provider (PQ).
General requests
Documentation must be provided in both Serbian and English translations.
Every day instructions for use must be in Serbian language
Documentation must be procured prior to qualification process starts
Instruction for use must contain information on general appearance, machine function, turn-on procedure, installation and maintenance processes instructions
Preventive maintenance program
Minor error removal procedure
Essential parts’ detailed list
European conformity certificates for all major system components.
Material certificates are required.