Flexible solutions for pharmaceutical processing

FAQs – Filling

Is 100% IPC necessary?
It is a huge advantage to use 100% IPC to save product and secure the process. The filling system, especially rotary piston pumps, is very precise and a reduced IPC rate is capable. Please note: a dynamic IPC rate could compromise the process security with line efficiency.

What is Advanced Fill on the vial filling module?
Advanced Fill avoids product loss and rejects during the start-up, and avoids emptying the vial filling module. With Advanced Fill, no rejects will be caused by the filling system, except the very last vial.

Is VarioSys® available for powder filling?
Yes, powder filling is available with an auger dosing system into vials. All filling modes and Advanced Fill are also standard with IPC for powder filling.

Which dosing principle is used for powder dosing?
B+S offers auger dosing which is very precise. Dosing volume >25mg.

Is powder and liquid filling possible on one module?
Yes, powder and liquid filling is possible on one module. Capping requires an additional module due to the footprint.

Which filling systems are available?
 • Powders: Auger dosing system
 • Liquids: Rotary piston pump filling system, peristaltic pumps, or a time/pressure filling system
 • Powder and liquid products can be processed on the same module
 • Multiple filling systems on one module are possible
The most suitable dosing system will be selected based on product characteristics and customer requirements.

Is there the capability for a Clean in Place/Sterilize in Place (CIP/SIP), system?
Yes, for liquid and/or powder filling.

Is Wash in Place (WIP) possible?
Yes, machines are designed for a manual WIP with spray guns. Automatic WIP is under development.

What type of peristaltic pump is used?
The exclusive B+S single-hose peristaltic pump is used. More info on request.

Is gas flushing possible?
 • KSF5105 filling and closing machine: gas flushing before and after filling
 • SFM5105 filling and closing machine: gas flushing during filling and during closing
 • A full nitrogen environment is also possible.

Is it possible to use scales on a mobile module?
Yes, anti-vibration compensation (AVC) technology is used to reduce vibration that might affect the performance of weigh scales.

Is IPC available on an ampoule filling module?
Yes, the AFV5105 is the first machine on the market which offers 100% IPC without reduction of speed.

Is it possible to integrate a filling system for disposable product bags or IV Bags?
Yes, Harro Höfliger offers a modular Aseptic Filling System for disposable product bags or IV Bags:
Aseptic filling of intravenous bags for parenteral and enteral applications is a highly challenging task. VarioSys® BFM is a modular platform designed for use in isolator-suitable applications for filling and sealing bags from 50 to 2000ml. The integrated mass flow filling system has a high level of accuracy and guarantees easy and complete cleanability. Also, this system can be connected to a fully automatic cleaning and sterilization system (CIP/SIP).

Is it possible to have the filling system outside the isolator?
Yes, a peristaltic filling system could be installed outside of the isolator.

How does a disposable fluid path function?
Located at the outside of the isolator, the disposable product path will be connected to the product tank at site via a sterile connector. The specific configuration will be determined during the project. B+S supports the configuration with the customer’s supplier.

Is filling of toxic/potent formulation possible?
Yes. For toxic applications, different pressure zones are used, a negative pressure within the isolator assures that no toxic product is "leaking". The SKAN PSI-L is equipped with a special H13 safe-change filter system for air return and a drainable gasket for L-flange.