With the development of new parenteral products and personalized drugs for small patient populations and the increasing trend for user-friendly and safer self-administration systems, pre-filled syringes and, more generally, ready-to-use (RTU) components, are becoming the preferred solution among the different parenteral dosage forms.
Vials have always been the preferred packaging materials for non-final sterile injection products, and they are widely used for sub packaging injection or powder for injection. However, with the rapid development of biotechnological drugs, pre-filled syringes began to rise from the 1980s, and promoted the rapid growth in parenteral primary packaging market. At the same time, the ready-to-use (RTU) nested packaging materials are becoming the preferred solution among the different parenteral dosage forms, such as the new packaging of nested vials, nested cartridges, double-chamber syringes and double-chamber cartridges are also successively entering the market. There are many advantages and benefits promote the development of RTU nested packaging solutions.
A Machine for Multiple Purposes
The trend of RTU pre-filled syringe is prominent. A large number of new projects have chosen RTU syringes. It is granted that RTU PFS was only suitable for small batch production but now large batch production with thousands of tubes also chose this kind of packaging material. At the same time, RTU packaging materials are gradually changing from niche products to attractive new alternative products for pharmaceutical companies. Manufacturers of glass packaging materials and plastics are contributing to this change. For example, the RTU nested vials and nested cartridge on the market now.
Figure 1: Transfer of bulk vials (left) and nested vials (right)
Equipment with Faster Lead Time, Faster Validation and Faster Market Response
The conventional filling line of bulk vials (for example taking bulk liquid injection vials) generally needs three clean workshops (C, B, C) in the primary packaging, while the pre-filled syringe filling line only needs two workshops (C, B). In terms of equipment requirements, since cleaning and sterilization have been completed before packaging, and the syringe has been sealed after being plugged, neither washing nor sterilization is necessary (Figure 2). For the size of the equipment, thanks to the nested design, the converying of containters is stremlined designed.There is no need for contanier
handling and complicated conveyoring belt, so the filling machine becomes much
2- Comparison between liquid injection vials (left) and pre-filled syringes
These characteristics will bring greate advantages.Less
equipment, smaller plant with simple utilities requirements can speed up the
process of the project, so that the plant can be built faster, the equipment
can be delivered faster, and the pressure of verification is greatly reduced especially
for expensive biopharmaceutics manufacuting. In this respect, the nested
packaging solution can provide pharmaceutical companies with satisfactory
answers. And Combo Filling's high compatibility with multiple packaging
materials enables pharmaceutical companies to respond to changes of packaging
materials in the market quickly.
Better-Small but Complete
Profit from the nested packaging characteristics, the compound filling machine can achieve more functions in a smaller space (Figure 3). For example, sampling 100% in-process control (IPC) function, CIP/SIP on-line cleaning and sterilization function, can be equipped with peristaltic pump and plunger pump filling system, integrated with vacuum filling and vacuum plug. The function of compound filling machine is even more comprehensive than that of conventional filling machine.
Figure 3- Conventional compound filling machine (Combo filling)
From the perspective of customer , the demand for personalized filling system is growing, such as high viscosity product filling, thick low viscosity product filling, small dose and high precision filling requirements.These personalized products challenge the conventional bulk filling solutions, and the nested filling system can easily integrate vacuum filling technology, plunger pump, time pressure method and other technologies .
Less Waste is More Profit
Compared with the conventional packaging materials, the nested syringe is more convenient to use, accurater in dosage, reducing product loss, which is exactly suitable for the expensive biopharmaceutical . In general, if choose the vials as the packaging, there may be about 20% - 25% overfilling. However, the nested syringes do not need the intermediate transfer containers, which can directly reduce the loss of overfilling. Similarly, the nested bottle has the same advantages. In addition, RTU packaging materials are often used in combination with disposable filling system, which can eliminate the need to clean and verify components in contact with products. The cleaning and validation is much expensive for biotech drugs.
The more kinds of packing can be filled and plugged on one machine, the more space is saved for users. Thanks to the new compound filling machine, the compound filling machine can handle all kinds of bottle types flexibly, which can save time and space in workshop and process validation. The nested packaging solution is obviously the best option for small and medium-sized biopharmaceutical manufacturers.
It is undeniable that the price of RTU nested packaging materials is expensive and the capacity of production line is lower than that of conventional bulk aspetic filling line. However, if the pharmaceutical company has limited space, limited funds for equipment in the early stage, but urgent require for equipment delivery compatible with mutil-containers special properties of drugs and other needs, RTU nested packaging and combo filling machine can a preferred choice.