PFS Auto Machine
PFS Auto Machine
For many years, the use of ready-to-use packaging containers (RTU) in the pharmaceutical industry has been steadily increasing. There are several reasons for this: increasingly smaller batch sizes, increased demands for flexibility in production and, above all, drop in prices for RTU packaging containers and, as a result, cost advantages for your investments.
Aseptic filling machines from Radiant Industries process pre-sterilized glass and polymer objects from almost all suppliers. A format changeover is possible without the use of any tools and thus creates only minimal set-up work, this shortens the downtime and enables maximum flexibility in aseptic processing. The areas of application inside the pharmaceutical industry are diverse: from CDMOs and Biologics up to Cell and Gene Therapies
Unlike to our PFS FILLING MACHINE the nested RTU containers are brought to the filler in the clean room, single or double bags, and is unpacked there using a semi or fully automated procedure. There are two main approaches for transferring the nested material into the aseptic area. The first option is outside decontamination with E-Beam, or by using H2O2. The other option is the no-touch transfer (NTT). In recent years, however, the no-touch transfer has slowly gained market share with small batch up to high-speed applications.
Processing pre-filled syringes with expensive parenteral drugs requires utmost care and precision. Radiant Industries comprehensive filling and closing s
this requirement, and many more: flexible handling allows for a gentle removal from the nest, while in-process control (IPC) further improves filling
through essential filling weight and stopper location measurements. The wide variety of filling systems, including peristaltic pumps, add to the over
hygiene. Vent tube or vacuum stopper insertion makes sure the syringes are tightly sealed.
Manually Tyvek lid removal and inner liner removal. Automatic filling by a piston pump. High accuracy of filling. Rubber stopper nest pick and please into stopping vacuum chamber by a mechanical arm. Automatic rubber stoppering in PFS by stopping the vacuum chamber. Easy access to the individual station because of the Narrow machine’s compact design.
Our filling systems
Hygienic filling and closing of nested, pre-sterilized syringes
Aseptic transfer possible with RABS or isolator
Fully automated processes with minimal operator intervention
Safe and gentle product handling
Technical Specification :
|Capacity (Speed Depend on filling volume & Viscosity)||RI-PFS per head/800-1000syringes/hr|
|Filling Process||Individual filling by servo|
|Dosing Volume||0.2ml-10ml (Available another size as an option)|
|Filling Nozzle||2,5,10 Head Nozzles|
Optional Accessories :
Documentation & Qualification
- In pharmaceutical production, Good Manufacturing Practices (GMP) are essential to guarantee that the manufacturing process is constantly controlled according to quality standards, and the drugs can be used safely.
- Therefore, there must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, ensuring clarity and traceability of the product quality data acquisition.
- At RADIANT INDUSTRIES, we defined specific actions to ensure that our document management, which we call GDP (Good Documentation Practices), fulfills this objective.
- Document management starts with the client’s specifications (URS) which help us understand the customer’s needs and define the machine’s configuration accordingly. The required machines’ functionality will be tested later during the qualification tests.
- The whole process is described in the picture below, showing the comprehensive Qualification Project Plan (QPP) that covers from mechanical assembly to software and control configuration: