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PZ Cormay SA is interesting in purchasing system / machine for ultrasonic coating of plastic parts made of PMMA and PS with water based solution of lithium heparin
If we are interesting below I am sending the specification – term for presenting the technical propose include the budget quotation untill 18.02.2015

criteria for vendor selection – achieving the highest level of factor “A”
Factor “A”-formula:

[P] Price 70% - calculated:
The best proposal / offering proposal

[D] Delivery term 10%
Less then 9 weeks 1point
From 9-12weeks 0,85 point
More then 12 weeks 0,7point

[M]2 years operation and maintenance costs 10%
The best proposal / offering proposal

[W] Warranty period 10%
2 years or more – 1 point
Less then two years – 0,5point

A=(0,7*P)+(0,1*D)+(0,1*M)+(0,1*W)



Specification:

Production Proses
Cormay needs machine which allow semi-automatic process of ultrasonic coating of plastic parts made of PMMA or PS with water based solution of lithium heparin. Coated with heparin will be microfluidic channel which is located inside of chip (both parts lower as well as upper). Coating will be performed before ultrasonic welding of both parts of chip.

Appliance has to have the ability to produce around 5.000.000 pcs of chips in total a year in 3 shift operation model. The machine should have a capacity to double production plan without significant investment. As an alternative continuous mode machine with conveyor can be proposed (belt with slots). Coating will be done in automatic mode by means of robotic system. Heparin has be sprayed exact in the channel, no full internal surface of chip can be coated. After coating plate with parts must be taking out from the machine in case using batch type machine or automatically transferred out in case using continuous machine with conveyor. Drying has to be performed during coating, drying temperature is room temperature, drying time less than 1 minute.

The system shall consist of the following units/sections:
a)            Manual insertion of chips with belt-type system as a buffer or plate in case batch type machine
b)            Coating arm, capacity at least 1.000 full chips/h (1.000 lower part/h + 1.000 upper part/h)
c)            Ultrasonic coating nozzle for micro dosing 120 kHz AccuMist
d)            Exit station
e)            5” exhaust flange for heparin vapours evacuation
f)             Control Panel (HMI)
g)            PC computer with software
h)            Working Chamber with lamp and door

Plate with slots for at least 16 chips (16 lower part + 16 upper part) for batch type machine – preferred solution. Plate to be easy mounted without tools on the machine table with position locking system which allows easy calibration and repeatability of spraying patter. Belt-type conveyer with slots for lower part as well as upper part of chip which allows to make a buffer between human handling plastic parts and automatic loading to machine.

Ultrasonic coating nozzle
Micro dosing ultrasonic coating nozzle with robotic arm with precise coating path.
Concentration of lithium heparin to be sprayed: 5 – 20 mg/ml
Possibility to use dosing syringe with volume from 1 ml up to 50 ml of spraying solution
Rate of flow for spraying solution: from 0,01 ml/min up to 5 ml/min
Speed of spraying from 1 mm/s up to 99 mm/s
Pressure of compressed air from 0,1 barg up to 6 barg
All critical coating parameters can be set on HMI and loaded from recipe.
Drying will be performed in spraying chamber:
Drying temperature: room temperature
Drying time: less than 60 s


VENDOR shall guarantee that the following acceptance criteria will be met:
Rate of flow for spraying solution ± 1% of declared value
Speed of spraying ± 1% of declared value
Line capacity within 5% to nominal value
 

The Control System shall be designed to monitor and control all the equipment supplied by the VENDOR. For Control System the GAMP 5 and 21 CFR Part 11 regulations are applicable.
VENDOR will deliver fully validable PC/PLC based control system in order to control and monitor functions within the SCOPE OF SUPPLY as listed below (but not limited to the following):

Recipes management enabling configuration, recording and archiving (min. 30 recipes) – each program consists of different steps for which different parameters will be defined (dosing volume, time, temperature, pressure etc.).
Data protection and operator access must be provided using user ID/password logging (identification).
Hierarchical access shall be based on different levels of authorization profiles – at least three: Operation, Supervision and Maintenance.
Batch Data Collection System (BDCS) – each product and batch process data shall be collected, electronically recorded and archived. Batch Report shall be generated.
Alarms, production stops and operation parameters changes with date and time shall be electronically recorded and archived. Protocols including this information shall be generated.
The system will operate in the manual and automatic mode. The operating mode can be change on each process step, with an administrator at the system.
In the automatic mode an operator shall be able to identify such data as batch information, date, time etc. before production run.
In the manual mode an operator shall be able to control all components of system for step by step processing, including calibration, product loading and unloading.
The set-up and reached parameters will be displayed. In manual operating mode an operator shall be able to control (within current range) all critical parameters of system components such as dosing volume, temperature, pressure, time etc.
Re-start shall be possible only based on operator's authorization (operator initiates recovery sequence). The system must re-start based on the last operational state before shut-down.
Equipment failures shall be recorded.
Machine hour counter should be in-built.
As a minimum, system must be fitted out with network port, printer port

User Interface
The system shall operate with a minimum of operator involvement and include a user interface located at/near the equipment, displaying operational information and enabling actions activation. The user interface system shall meet following requirements:
Standard Dell PC monitor on extension arm
Control panel flush on the supporting structure, extension arm or wall mounted.
Cleanroom keyboard

Operator panel shall provide the necessary switches, indicators and devices to operate the equipment. Following user interfaces are required to be included in the computer control system, as a minimum:
Start/stop buttons.
Jog/Run selector.
Emergency stop button(s).
Run status indication light.

Data Collection
Batch data records are created and outputted in .xml. The CLIENT is responsible for processing the collected data report, and shall include the following information:
Product information (name, code).
Manual input of batch identification (number).
Operator identification.
Equipment identification.
Manual input of facilities set-up information.
Start and end dates and times.
Process/product parameters.
Production stops and changing of operational parameters with date and time.
Calibration process
Errors.
Other alarms.

Safety
In the event of a power failure, the system shall ensure:
Personnel protection – all driven machinery stops,
Equipment protection – equipment shall stops avoiding damage,
Product protection – product shall be protected from product quality degradation.

VENDOR shall provide following safety interlocks:
Emergency stop.
Control power fault.
Common trouble.

Emergency stop(s) shall be large mushroom type button, hardwired. Upon actuation, the entire system shall shut down immediately and shall de-energize all elements of the system inside the spray chamber.
The emergency stop mechanism(s) shall be located in easily accessible areas around the equipment and location(s) shall be indicated on the equipment drawings.
In the event of a power failure during a production run, all information regarding the status of the run shall be automatically stored.

Standard electrical system of the VENDOR shall be applied with protection IP54 or higher (according to Ex-protection requirements, where applicable).

Machine has to respect GMP and FDA regulations

Contact person:

Tomasz Ksyta
Purchasing Manager
-----------------------------------------------------------------------------------

PZ Cormay S.A.
Purchasing Department
Office adress:
02-785 Warsaw
Puławska 303
Poland    E: tomasz.ksyta@cormay.pl
M: +48 695 151 070
T:  +48 81 749 44 91


 





 

PZ CORMAY Spół‚ka Akcyjna wpisana w Są…dzie Rejonowym dla m.st. Warszawy w Warszawie, XIV Wydział‚ Gospodarczy Krajowego Rejestru Sądowego pod nr KRS:0000270105,
NIP: 1181872269, REGON: 140777556. Wysokość‡ kapitał‚u zakł‚adowego Spół‚ki: 63 723 954, 00 PLN, wysokość‡ kapitału wpł‚aconego Spół‚ki: 63 723 954, 00 PLN.