Pharmaceutical industry
FP Sterile
Output up to 220 tubes/min.
The FP Sterile platform for tube filling is the only tube filling machine worldwide to meet all relevant EDEHG and cGMP guidelines. It enables all paste-like products to be filled into metal, plastic or laminate tubes under sterile conditions.
Benefits:
- The materials used mean the machine surface can be sterilized by means of gas purging with hydrogen peroxide (H2O2). Disinfection is generally performed via alcohol-based rapid disinfection;
- All angles between parts and components that are in contact are ≥90° and are equipped with seamless seals that are approved for filling and cleaning;
- All components and sensors in the FP Sterile tube filler platform are fully encapsulated, making them easy to clean;
- Glove ports are installed at all the key manual access points on the machine;
- In the event of product or batch changeovers, all product contact parts can be cleaned and sterilized using the integrated CIP/SIP system, without needing to be removed and reinstalled;
- There is no scope for potential ‘dead spaces’ where residues or bacteria could accrue and propagate;
- All product contact parts are electropolished and have a surface finish of ≤ 0.8 μm as standard;
- In the product area and on process valves, the seals used are produced from FDA+EMEA/410/01-certified silicones and FPM. In the injection and non-product area, seals are made from FPM (Viton®);
- Format parts with a surface finish of at least Ra ≤ 0.8 μm are manufactured from the heat-resistant and durable plastic PVDF (polyvinylidene fluoride) or PEEK polymer. These materials are not sensitive to high temperatures (up to 130°C in autoclaves), nor the cleaning agents used during sterilization;
- The machine is controlled via a stainless steel version of the user-friendly IWK operator panel with a 15.4” monitor.
Applications:
Products:Sterile filling of products that do not use preserving agents or stabilizers; sensitive products and those that need to meet high hygiene standards; ointments, eye ointment creams, and eye creams.
- Tube material:
Aluminum, aluminum laminate, polyethylene, polyethylene laminate, coex.
- Tube shapes:
Cylindrical.
Specifications
Type | FP 34-1 | FP 46-2 |
Max. output (tubes/min.) | 120 | 120 |
Number of tube holders | 34 | 46 |
Number of filling heads | 1 | 2 |
ø Plastic & laminate tubes (mm) | 10 - 52 | 10 - 52 |
ø Metal tubes (mm) | 10 - 40 | 10 - 40 |
Tube length (mm) | 60 - 250 | 60 - 250 |
Volume (ml) | 1.5 – 350 | 1.5 – 350 |
Small footprint, maximum accessibility, GMP design |