FFS 9105 MACHINE :
SteriMax India has successfully developed total indigenous and most economical Version of Blow Fill Seal (BFS) Machines which meets to the requirement of pharmaceutical industry. Our complete design of BFS Machine meets to the cGMP norms & US FDA Regulatory obligations. All Product contact parts are made up of SS 316L, non-Contact parts are in SS 304.
Machine is facilated with In-Situ CIP(Cleaning In Place) / SIP (Sterilization In Place) which provides printed records of sterilization cycle as documentary evidence. Integrity of Product and Air Filters can also check and recorded. SteriMax India BFS Machine is designed to Integrate Filling Cycle in continuous manner over the single machine under class 100 environment to ensure complete aseptic production in most economical way. All machines are provided with DQ /IQ /OQ /PQ documentation.
Advantages Of SteriMax BFS Machine
No Cross Contamination.
Design as per cGMP norms.
No Human interventions.
High Level of sterility Assurance.
Ease in operation.
Zero Leakages.
In Situ Sterilization (CIP/SIP).
Suitable for all type of Pharma liquid filling.
SVP-Eye Drops, Ear Drops.
LVP IV Fluids.
Water for irrigation.
SVP- Filling Range 0.2 ml to 30 ml.
LVP- Filling Range 50 ml to 3000 ml.
Nitrogen Flushing During filling (optional).
Complete Validation of machine & process.
Time and Pressure Dosing (TPD) for accurate filling.
Sanitary type zero dead leg valves.
24 X 7 Online Support.
FFS 9105 MACHINE
Basic Features :
Small Volume Parenteral format machine (SVP).
Product range varies from 0.2ml to 30ml.
Available in both servo-hydraulic and all electric (servo) options.
Operator friendly with full colored touch screen display.
High speed production machine.
Compact design as per cGMP norms.
Technical Features & Accessories :
Entire machine motions are electrical servo motor controlled for servo machine.
Machine comes with the latest Siemens PLC S7-1500.
Provision for data logging/audit trails.
Provision for data storage, SCADA, cloud etc.
Facilitate with auto CIP/SIP with print and batch report.
Spacious design for easy maintenance and changeover.
Provision for online velocity monitoring and differential pressure monitoring.
Provision for active air sampling.
Provision for passive air sampling using an online particle counter.
Provision of ultrasonic cutter/cold knife for parison cutting.
Very less running cost of electricity consumption.
Maximum power consumption 35 units/hr.
Machine runs with low noise and less vibration.
Machine follows the FDA: 21 CFR Part 11 compliance.
EU Annexure 1 compliance.
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