FFS
FORM FILL SEAL (FFS)
SteriMax India has successfully developed total indigenous and most economical Version of Form Fill Seal (FFS) Machines which meets to the requirement of pharmaceutical industry. Our complete design of FFS 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 FFS 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 FFS 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-3105 MACHINE
Basic Features :
- Small Volume Parenteral format machine (SVP).
- Product range varies from 0.2ml to 30ml.
- Operator friendly with full colored touch screen display.
- High Speed Production machine.
- Compact design as cGMP norms.
- No Cross Contamination.
Technical Features :
- Entire machine motions are Electrical Servo Motor controlled.
- Machine comes with latest Siemens 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 and 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.
- Very less running cost of electricity consumption.
- Maximum power consumption 30 unit/hr.
- Machine runs with low noise and less vibration.
- Machine follows the FDA: 21CFR Part 11 compliances.
SMALL VOLUME PARENTERALS (SVP)
| PRODUCT NAME | UNITS | RESPULES | WFI | EYE DROPS | WFI |
|---|---|---|---|---|---|
| MODEL 3105 | 0.5ML | 3ML/ 5ML | 5ML/ 10ML | 5ML/ 10ML | 20ML/ 30ML |
| CAVITIES | 30 | 30 | 25 | 18 | 18 |
| MOULDS | SINGLE | COMBO | COMBO | COMBO | COMBO |
| CAPACITY / HR | 7500 | 7500 | 6500 | 4600 | 4600 |
| MODEL 9105 | DOUBLE | DOUBLE COMBO | DOUBLE COMBO | DOUBLE COMBO | DOUBLE COMBO |
| CAVITIES | 60 | 60 | 50 | 36 | 36 |
| CAPACITY / HR | 15000 | 15000 | 13000 | 9200 | 9200 |
| MODEL 8166 | 0.5ML | 3ML/ 5ML | 5ML/ 10ML | 5ML/ 10ML | 20ML/ 30ML |
| CAVITIES | 50 | 50 | 40 | 30 | 30 |
| MOULDS | SINGLE | COMBO | COMBO | COMBO | COMBO |
| CAPACITY / HR | 13500 | 13500 | 11000 | 8000 | 8000 |
| MODEL 9166 | DOUBLE | DOUBLE COMBO | DOUBLE COMBO | DOUBLE COMBO | DOUBLE COMBO |
| CAVITIES | 100 | 100 | 80 | 60 | 60 |
| CAPACITY / HR | 27000 | 27000 | 22000 | 16000 | 16000 |
