BFS Machine-540
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.
- 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.
Basic Features :
- Large Volume Parenteral format machine (LVP).
- Product range varies from 50ml, 100ml, 250/300ml, 500ml, and 1000ml.
- Operator friendly with full colored touch screen display.
- High Speed Production machine.
- Compact design as per GMP norms.
Technical Features :
- Machine motions are Electrical Servo Motor controlled.
- Machine comes with latest PLC S7-1500.
- Provision for Data Logging/ Audit trials.
- Provision for data storage, SCADA, Cloud etc.
- Facilitate with Auto CIP/SIP with printout and Batch Report.
- Spacious design for easy maintenance and changeover.
- Provision for online velocity monitoring or differential pressure monitoring.
- Provision for Active air sampling.
- Provision for Passive air sampling using online Particle Counter.
- Use of Ultrasonic Cutter/ Cold Knife for Parison cutting.
- Provision of PWTC for parison head.
- Very less running cost of electricity consumption.
- Maximum power consumption 35 unit/hr.
- Machine runs with low noise and less vibration.
- Machine follows the FDA: 21CFR Part 11 compliances.
• Large Volume Parenteral format machine (LVP).
• Product range varies from 50ml, 100ml, 250/300ml, 500ml, and 1000ml.
• Operator friendly with full colored touch screen display.
• Available in hydraulic motion configuration.
• Machine comes with latest Siemens PLC S7- 1500.
• Provision for Data Logging/ Audit trials.
• Facilitate with Auto CIP/SIP with printout.
• Step design for maintenance and changeover.
• Provision for PWTC for parison head.
| PRODUCT NAME | IV FLUIDS | IV FLUIDS | IV FLUIDS |
|---|---|---|---|
| MODEL 540 | 50ML/ 100ML | 100ML/ 300ML/ 500ML/ | 100/ 300/ 500/ 1000ML |
| CAVITIES | 12 | 8 | 6 |
| MOULDS | 100ML | 100ML/ 300+500ML | 300ML/ 300+500ML/ 1000ML |
| CAPACITY / HR | 3350 | 2050 | 1500 |
| MODEL 940 | 50ML/ 100ML | 100ML/ 300ML/ 500ML | 100/ 300/ 500/ 1000ML |
| CAVITIES | 24 | 16 | 12 |
| MOULDS | 100ML | 100ML/ 300+500ML | 300ML/ 300+500ML/ 1000ML |
| CAPCITY / HR | 6700 | 4100 | 3000 |
