1.0 Basic Details Blow Fill Seal Machine - Double Station
Intra Venous (IV) Fluid.
1.3 Drawings for the mould
Shall be submitted after receiving the sample from the customer.
1.4 Mould design
As per customers sample or specification.
1.5 Mould Material
STAVAC / AL. Bronze material with SS 304 back plate.
1.6 Product Output / Machine
500 ml bottle – 1300 bottles per hour.
1000 ml bottle – 1000 bottles per hour.
2 moulds for 500 ml ( 4 cavity each )
2 moulds for 1000 ml ( 4 cavity each )
1.7 Plastic Material
LDPE / PP :-
3020D Basell, LE 6607 Ineos / Borealis, FE 8000 Qatar Petrochemical
BB 120 LG Chem
Room temperature: 23 Degree C (+/- 2°C) (not below 15 Degree C)
Voltage tolerances - max, ± 10 %
Cooling water temperature at full load - max. 12 Degree C
2.0 Basic Machine
2.1 Machine Base
Stable stainless steel welded structure of machine base frame to accommodate the mould filling station , extruder and other assembly components for machine operation. The finishing of the appearance parts is 2B.
2.2 Locking units 2 sets with stainless steel 304 construction.
2.3 Central Lubrication with cycle controlled (automatic)
2.4 Vacuum System and allowing WFI (water for injection) through the vacuum system and line for mould cleaning.
2.5 Pneumatics system is supplied through central connection, to use Festo / Legris products brand and the PnID will be issue.
2.6 Hydraulic system using proportional valve, complete with oil tank, hydraulic pump, high pressure hose, cooling system and valve control system. The equipment brand to be Yuken for valve system.
2.7 Extruder with Gear Box and Drive AC with variable speed control.
2.8 4 Parison Head with 110mm centre distance and with 3 points parison control
2.9 Special filling head aseptic design (SS316L)
2.10 Aseptic Time Pressure Dosing device with pneumatic actuated in step for each filling nozzle.
2.11 SIP, CIP, Filter Drying arrangement and control system in PLC ( program logic control )
2.12 Smoke arrester system
Evacuation of particles on the machine for extruder (closed casing complete with v - belt drive with exhaust conduit, air exhaust of all pneumatic valves , air escape of vacuum pump , air exhaust for parison head and hot cutting wire .The blower to be installed at Black Area.
2.13 Filling Chamber construed with SS304 with class 100 area around filling nozzle complete with port or particle count. The size of the filling chamber to be designed to achieve better flow for particle count results reading. The air inlet ducting to be designed for SIP process complete with pneumatic damper control.
2.14 Extruder system.
Diameter 65 mm with Length / diameter ratio 24:1, complete in respect with gear box, 20 HP motor with variable speed control.
All covers and gates will be interlocked electrically for safety reasons.
2.17 Control Panel
All the process movements of the mould, blow molding, aseptic valve controlling, SIP, CIP and Filter Drying mode filling parameter setting to be controlled and operated at main control panel.
2.18 Black and White concept
All the mechanical parts such as Hydraulic system, vacuum system, valves bus block, electrical and instrument parts will located at a different area (black area) while blowing and filling station.(white area) There are exhaust systems located at the blowing station to remove the particle and dissipate heat.
2.19 Temperature Recoding and Data Logger
PT 100 sensor to be used at 12 specified locations based on PnID.
The data (temperature reading) able to be transmitted to a printer.
Data logger ,Cannon printer( using normal paper ) and PT 100 sensor to be supplied.
2.20 Calibrating Certificate for measuring devices
All the measuring devices ( PT100 , sensor, pressure transducer ) which are part of the aseptic system will be calibrated.
2.21 Filter Housing
Two (2) systems of Filter Housing complete with pipeline and fittings.
(solution and air). SS 316L construction and internal roughness max 0.4 - 0.6 micron for the housing.
3.0 Aseptic System
3.1 Aseptic Valves
Stainless Steel 316L body construction and silicon diaphragm to be used for 2/3 and 1/2 way valve with internal electro polishing. The surface roughness max 0.4 - 0.6 micron. Design for working pressure max 2.5 bar at temperature of 135 Degree C with pure steam media.
3.2 Buffer Tank , 20 L
Pressure equalizing with hermetically closed , dustproof , sterilizable with pure steam ( SIP ) , hot water clean in place ( CIP ) , automatic recharging system for product solution. The tank designed and constructed according to the DOSH requirement. Internal roughness max 0.4 - 0.6 micron.
3.3 Aseptic Cabinet
All the aseptic equipment (valves, CIP tank collector, steam trap) to be installed in specified cabinet in white area.
3.4 Aseptic Process Sequence
The program selector to allow the following automatic sequences of aseptic valves actuation for the following process :
- Cleaning In Place (CIP)
- Steam In Place (SIP)
- Filter drying.