Pre-Filled syringe Line
Pre-Filled Syringe Filling & Stoppering Machine Process
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.
Outside decontamination, irradiation or aseptic no-touch transfer (NTT)
No-touch transfer (NTT) basic
No-touch transfer (NTT) advanced
Opening tubs without risk of contamination
Filling and closing of RTU containers
Systems with Statistical In-Process-Control (IPC)
Aseptic filling equipment with 100% In-Process-Control (IPC)
First-Class Technology And Innovations For Processing Syringes In Bulk
Pre-filled syringe is a new type of drug packaging developed in 1990s. After more than 30 years of popularization and use, it has played a good role in preventing the spread of infectious diseases and the development of medical treatment. Prefilled syringes are mainly used for packaging and storage of high-grade drugs and are directly used for injection or surgical ophthalmology, otology, orthopedics, etc.
Radiant Industries is the best in Pharmaceuticals industries for Pre-Filled Syringe & Stoppering Machine we are introducing new development is Automatic Pre-Filled Syringe Filling & Stoppering Machine. Very compact and elegant PLC. Based CGMP model for automatic filling and stoppering operation of pre filled syringes.
- PFS Overfill is generally 20-25% while PFS Overfill is 2%. As a result, potentially 18-23% more doses can be produced, which results in increased use of API & more doses per unit of drug production.
- Yield is thus maximized which indirectly results in cost reduction.
- Overfill can also cause dosing errors that are virtually removed with PFS.
- PFS is most advantageous if drugs / vaccines are in short supply or are really very costly.
- PFS reduces the risk of Needle-Stick Injury. World Health Organization (WHO) estimates * that there are 3 Million accidental Needle-Stick Injuries (considered Occupational Hazard) worldwide.
- Accurate, Pre-Measured Dose lowers risk of Dosage Error because PFS actually contains the Exact Dose.
- The final container used to administer the drug to the patient is clearly labeled. PFS eliminates risks of misidentification & mix-ups, which are particularly dangerous when highly potent drugs are in play.
- Shortest Injection Preparation Time as it contains Fewer Processing Steps.
- Time Saving in Transfer of Drug from Vial to Syringe.
- PFS can be effectively used for any type of Viscous Fluid.
- Easy Storage & Disposal.
- Reduced Bulk Formulation Cost.
- Minimizes Microbial Contamination.
Pre-Filled Syringes (PFS) is a modern way to apply Parenteral Drugs in an Aseptic manner. PFS has an excellent market acceptance & increased market preference due to following advantages:
- Processing of all commercially available ready-to-use syringes (glass and plastic)
- Processing of all commercially available syringes nested in tubs and bags
- Aseptic fields of application
- Dosing system: Rotary piston system, peristaltic pump system, time/pressure dosing system with or without CIP / SIP optional
- Processability of three different container types (vials, cartridges and syringes)
- Simple operation
- Flexible adjustable filling movement
- Vacuum filling and vacuum stopper insertion optional
- Statistical In-Process-Control (IPC)
- Compact design
- Horizontal and longitudinal processing of the tubs is possible
- Appropriate for oRABS, cRABS and Isolator
- Easy and fast format change
- Very good ability to be cleaned
- Very good accessibility
- Teach-in function of stations
- Pre-, fill- and post-gas flushing optional
- Processability from watery to highly viscous products, as well as highly potent and non highly potent products
- Small amount of format parts
There are 4S main advantages to share with you about our machines.
- Safety. Our machines are equipped with protective cover, when the machine is running, the cover is closed, when the cover is open, the machine will stop running, which prevent worker from injury and also there will be no dust pollution to pollute syringe in process.
- Stable running. Our machine is capable of running 8 hours a day but if you plan to run it for 16 or 24 hours per day our machine can keep stable running 24 hours per day. So you can make the production shifts according to your demand. If you need more production and advance machine we are capable of making advance machines as per your needs.
- Save labors. Save labor cost. It is fully automatic controlled by PLC. The machines are connected together. Not separate ones. It can do printing, assembling in one connected line. No need labors to do the transfer when printing is finished. Finished printing product will be transfereed to assemabling machine automaticlly.
- Save materials. Our machines have high qualified rate. It is more than 99.9%. There will be almost no waste for you. More qualified product, more profit.
Product Working Video
Pre-filled syringes are recognized as an efficient, reliable and convenient method for drug administration in healthcare Industry. Radiant Industries provide innovative machines for PFS filling, stoppering, plunger rod insertion and labelling operations following the Aseptic Guidelines.
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: