Double chamber pre filled needle freeze-drying product

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Beijing Songyuan Huaxing Technology Development Co., Ltd

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Date: 2022-09-21Read: 8

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Preface

The vast majority of freeze-dried products on the market cannot be simply combined with standard syringes because they require a reconstitution step before administration. But for home care and emergency use, people still expect to reduce the requirements for operational steps and professional use. Under this demand, the Dual chamber system (DCS) can provide a better option, allowing for in-situ reconstitution and administration. Due to the high proportion of freeze-dried formulations in approved biopharmaceutical products, DCS is expected to show an upward trend and may become a major player in the emergency and home care marketssouxuanProduct. However, until today, due to challenges and limitations in manufacturability, product formulation, and stability of the dual cavity structure, as well as economic considerations, there are only a few products on the market.

Dual chamber pre charging needle

Double chamber pre filled needle is an extension of conventional pre filled needle, which is designed with two chambers in the conventional pre filled needle. One chamber stores the freeze-dried active ingredient, and the other chamber is filled with a matching dilution solution. This design has similar advantages to water-based pre filled needles, while retaining the advantage of easy preservation of freeze-dried formulations.

When in use, push the core rod piston and use pressure to press the central rubber plug through the bypass passage on the cylinder wall, allowing the dilution solvent to flow into the chamber where the freeze-dried formulation is located through the "passage", and then mix and use.

Application of Freeze Drying Technology

Vacuum freeze-drying, also known as freeze-drying, refers to the process of drying solid materials directly into a gaseous state without going through the liquid phase under vacuum conditions. During the freeze-drying process, the solvent directly sublimates from the solid state to the gas state, so it does not destroy the original chemical structure and form of the solute. Materials with biological activity can still restore their conformation and biological function before freeze-drying after re dissolution. Therefore, freeze-drying is a safe drying method with minimal impact on the properties of the dried substance.

The production process is roughly shown in the following figure:

For this production process, due to the special structure of the dual chamber pre filled needle, the contact surface between the bottle body and the plate is very small, which means that the energy required for the freeze-drying formulation during the freeze-drying process is more through convection and thermal radiation rather than heat conduction. The energy source is roughly the same at different stagesas follows:

Pre freezing: convection>thermal radiation>conduction

Drying: Thermal radiation>convection>conduction

thisalsoIt meansFreeze drying temperature of its productsindirectTemperature control of freeze-drying machine plate layer.

Of course, the double chamber pre filled needle can be fitted with a sleeve or other set to make the needle tube wall in contact with the metal sleeve, thereby increasing the impact of heat conduction on the process. The entire process design should ensure the sterility of the process.Besides,There are also slightly different production processes (contact between syringe cap and freeze-drying machine board layer):

This methodUnder the formula,Dual chamber pre charging needleThe cooling rate is still slower than that of conventional penicillin bottles, about40%And the final pre freezing temperature is higher than the layer height of the board8.2centigrade.

Therefore, it is recommended to explore the process as much as possibleDesign SpaceThe concept is applied in research and development, scaling up, and transfer to understand the impact of packaging material specifications (from different suppliers), drug solutions (composition, filling volume), and process parameters on the final properties of the product.

The freeze-drying products in the top chamber of the dual chamber system DCS have two forms of production process:

1. Needle up "

Compared to traditional production methods, packaging materials first need to be cleaned, sterilized, and siliconized. Then, a middle plunger rubber plug is inserted through the open end of a glass syringe barrel, and the DCS is flipped over so that its head always faces up. The products that need to be freeze-dried are filled into the corresponding chamber through the DCS head. Obviously, this requires a relatively large opening at the top of the glass container, and glass syringes with small diameters such as Ruhr cones cannot be used. Then place it in a supporting container, such as a positioning bucket Puck or a loading box Magazine (as shown below), and transfer it to the freeze dryer for freeze-drying. After freeze-drying is completed, the top sealing cover is pressed and sealed through the board layer, and then enters the next diluent filling process.

2. Needle down "

This PFS production mode, based on the commonly used RTU packaging material, does not require the DCS to be flipped throughout the entire production process. After filling the liquid that needs to be freeze-dried, the glass syringe is directly placed into a specially designed support container and then enters the freeze-drying machine to complete the freeze-drying process.

No matter which form of production process is mentioned above, different forms of supporting containers will be used. The design of supporting containers is not only to consider the stability of DCS transportation, but also to increase the contact area between DCS glass cylinder and freeze-drying machine plate layer, so as to maximize efficiencyImprove heat conduction efficiency. This is because regardless of the form, the contact area between the DCS glass tube and the plate layer is extremely limited, resulting in a significantly different freeze-drying process from that of penicillin bottles. In other words, the design and material selection of the supporting container are directly related to the thermal conductivity efficiency of DCS during the freeze-drying process.

product status

There are two common types of DCS on the market, pre filled needle PFS and cartridge bottle, with the main difference being their head closure design.

The following table lists 13 DCS products on the market, of which 5 are dual chamber syringes and the other 8 are dual chamber cartridges. However, this does not mean that there is any so-called trend in the selection of syringes or cartridges.

Conclusion

At present, only a few companies in the market provide freeze-drying products with dual chamber systems, and due to the volume limitations of pre filled needles or cartridge bottles, the vast majority of products have a capacity of 1ml~5ml. However, it cannot be denied that this form of administration is convenient for home care and emergency medication, and there should still be a large potential market waiting to be explored.

In addition, the current production methods rely on traditional freeze-drying techniques, such as using freeze-drying machines to load layers, which makes the entire process appear too complex.

Introduction to Songyuan Freeze Drying Company

Beijing Songyuan Huaxing Technology Development Co., Ltd. was founded in 2000, focusing on the research and development, production, and sales of vacuum freeze-drying technology products. With "vacuum freeze-drying machine" as the core product, it has formed three series of products and targeted solutions for scientific research experiments, medical, and food industries, with different scales and applications. It is an influential supplier of vacuum freeze-drying equipment and targeted solutions in China.

Beijing Songyuan Huaxing is a national high-tech enterprise and a Beijing industrial enterprise safety production standardization enterprise. It has passed ISO9001:2015 quality management system certification and EU CE certification. Headquartered in Beijing, with branch offices and authorized maintenance stations in Shanghai, Guangdong, Wuhan, Xi'an, Chengdu, Fuzhou, Nanjing and other places. Meanwhile, Beijing Songyuan HuaxingThe products are exported to countries such as the United States, Russia, South Korea, Japan, Singapore, Malaysia, and Canada.

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