Blow Fill Seal (BFS) 8166 :
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.
BFS-8166 MACHINE
Basic Features :
Large Volume Parenteral format machine (LVP).
Product range: 50ml, 100ml, 250/300ml, 500ml, and 1000ml.
User-friendly with a full-colored touch screen display.
High-speed production capability.
Compact design adhering to GMP norms.
Technical Features :
Machine motions are Electrical Servo Motor-controlled.
Equipped with the latest PLC S7-1500.
Provision for data logging and audit trails.
Supports data storage on SCADA, cloud, and other platforms.
Automated CIP/SIP with batch report generation.
Spacious design for easy maintenance and changeover.
Online velocity or differential pressure monitoring support.
Active air sampling capability.
Passive air sampling using an online particle counter.
Ultrasonic cutter or cold knife for parison cutting.
Parison head with PWTC (Programmable Wall Thickness Control).
Low operating cost with a maximum power consumption of 35 units/hour.
Operates with low noise and minimal vibration.
Fully compliant with FDA 21 CFR Part 11 standards.
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