Fully Pre-Filled Syringe Production Line

Pre-Filled syringe Line

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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)

The transfer of the containers to the aseptic area is a crucial in the pharma industry. Particularly, in the case of small and medium-sized production quantities, the so-called no-touch transfer (NTT) provides an option for aseptic transfer, which is becoming increasingly important alongside decontamination with E-Beam or H2O2.

As the leading supplier of filling and closing of nestes nested syringes, vials and cartridges, Radiant Industries was one of the first pharmaceutical machine manufacturers whose liquid filling machines were commissioned in combination with an E-Beam or the no-touch transfer technology and approved by the regulatory authorities for GMP production.

In the area of non-contact aseptic transfer, it is differentiated between different stages of development:

No-touch transfer (NTT) basic

With the compact NTT basic, the RTU objects are packed in two plastic bags and delivered to the line. The outer bag is manually cut open under a class A laminar air flow and then the tub in the inner bag is pushed over into the class B zone. There the bag is automatically clamped, cut and the tub is transferred semi-automatic to the aseptic filling area (isolator class A/ISO 5)

No-touch transfer (NTT) advanced

The nested objects are also delivered in two bags for the fully automated NTT. The outer bag is clamped manually or automatically at the machine, cut open, and the tub in the inner bag is moved over to Class B. This is followed by fully automated bag stretching, followed by fully automated clamping and cutting. The tub is then transported to the aseptic core area (clean room class A/ISO 5)

H2O2

For decontamination with H2O2, a single-packaged bag is manually cut open under laminar class A air floor and transferred to the decontamination chamber. A 6-log outside decontamination of the RTU tub is then carried out using H2O2 and a manual or automatic transition to class A.

E-Beam

For the E-Beam outside decontamination, single bagged RTU containers are unpacked and fed into an e-beam chamber at up to seven units per minute. This allows for a safe procedure with a 6-log rate, which means that the packaging can be introduced sterile.

Opening tubs without risk of contamination

Radiant Industries uses the patented pull-off rollers to open tubs. In this step, the adhesive points of the packaging cover are first heated to loosen the adhesive bond. It also minimizes the generation of particles when the liner is pulled off. Vacuum rollers pull off the lid and liner at the same time at a uniform speed in an extremely process-reliable and reproducible manner.

This also guarantees ideal first-air contact, i.e. there is no movement above the opened containers, which prevents the primary packaging from becoming contaminated with particles.

Irrespective of the machine's output, this technology enables continuous processing independent of the actual batch size.

Filling and closing of RTU containers

How to fill a prefilled syringe, vial or cartridge? There are two basic technological approaches for filling a liquid pharma product into a RTU container: It is differentiated between a automatic filling machine with a Statistical In-Process-Control (IPC) and fillers with a 100% In-Process-Control (IPC). The decisive difference between the two methods is whether and when the objects are lifted out of the tub or nest and weighed.

Other steps like filling or stopper placement with vacuum, gassing of oxygen sensitive products as well as the use of various filling systems (i.e. rotary piston pumps, peristaltic pumps or time-pressure system) can be realized with both types.

Systems with Statistical In-Process-Control (IPC)

For fillers with Statistical IPC, the objects can remain in the nest during filling and stoppering. The number of weighing processes can be set via the user interface, the objects are lifted out with robotic arms and weighed before and after filling.

With these syringe filling machine or cartridge filling machine the objects remain in the nest after they have been closed and can be inspected after they have been removed from the aseptic area.

The procedure may be different for a vial. If they are closed with integrated stopper caps, the process is similar to that for a syringe and cartridge. However, if they are to be sealed in the traditional way with stoppers and aluminum caps, the vials are lifted out of the nests by a robotic arm and individually fed to the crimping machine.

Aseptic filling equipment with 100% In-Process-Control (IPC)

Vial, cartridge and syringe filling machines with 100% IPC are characterized by the fact that all containers to be filled are brought individually into a transport system after the lid and liner have been removed from the tub.

Since the separation is done with a robot arm, this only has a minimal impact on the laminar flow around the objects. Manipulated they can also be weighed individually. With these systems, it is possible to define the filling range even more precisely, since direct adjustment is just as possible as redosing or replacing missing stoppers.

The smart fill feature established by Radiant Industries also minimizes product loss in these systems when starting up or running empty.

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 has several other benefits like

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.

PFS Features

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

Advantages of PFS

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: