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Advantages of RTU Nested Packaging Solution
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
compact.

Figure
2- Comparison between liquid injection vials (left) and pre-filled syringes
(right)

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.

http://www.tofflon.com/en/news-detail.html?news=13755[7/31/2021 5:27:33 AM]

 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.

Summary

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.

need for contanier handling and

complicated conveyoring belt, so the filling machine becomes much compact.

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http://www.tofflon.com/en/news-detail.html?news=13755[7/31/2021 5:27:33 AM]