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Aseptic Filling Production Process for Vial Filling Machine

2023-11-27

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Marya

During the final product filling production, sterile methods and techniques are used to package sterile products in clean and controlled sterile vial bottles. Biopharmaceuticals are often produced using partial or complete aseptic production processes due to the inability of their components to be processed using final sterilization processes. The sealing of the drug solution must be carried out in a sterile environment, and automated equipment should be used as much as possible to reduce manual intervention and reduce the risk of contamination, such as using isolator filling lines.

During the final product filling production, sterile methods and techniques are used to package sterile products in clean and controlled sterile vial bottles. Biopharmaceuticals are often produced using partial or complete aseptic production processes due to the inability of their components to be processed using final sterilization processes. The sealing of the drug solution must be carried out in a sterile environment, and automated equipment should be used as much as possible to reduce manual intervention and reduce the risk of contamination, such as using isolator filling lines.

 


1.Equipment preparation——Vial Filling Machine     

According to whether the components come into contact with the product, it is generally divided into direct contact, indirect contact, and no contact. Based on the contact between components and products, combined with quality risk assessment, develop strategies for component cleaning, sterilization (disinfection). For products that come into direct or indirect contact, they are usually cleaned, disinfected (sterilized) before/after use; Determine whether disinfection (sterilization) is necessary based on relevant evaluations for those that do not come into contact with the product; Those entering the sterile area must be cleaned and sterilized (disinfected) regardless of whether they come into contact or not.


2.Moist heat sterilization——Vial Filling Machine

The wet heat sterilization method refers to the use of high-pressure steam or other thermal sterilization methods in a sterilizer to kill microorganisms, which has the characteristics of strong penetration, fast conduction, and stronger sterilization ability. It is one of the most effective and widely used methods in thermal sterilization. Drugs, glassware, culture media, sterile clothing, rubber stoppers, and other substances that do not change or damage when exposed to high temperature and humid heat can be selected. Pulse vacuum sterilization program is a commonly used sterilization program for wet heat sterilization. This program belongs to a method of saturated steam sterilization, which involves removing air from the chamber through a vacuum pump or other system before the sterilization stage begins, and then introducing saturated steam for sterilization. Pulse vacuum sterilization programs are often used for loads that can contain or contain air, such as hoses, filters, and filling machine components.

 

   

 


3.Sterilization and filtration——Vial Filling Machine

Usually, sequential or redundant filtering is used. The selection of filters first needs to determine the material and pore size according to the requirements, then design a scaled down test to determine the filtration membrane area, and finally select a suitable filtration device based on actual process requirements.
Before use, sterilization and filtration must be carried out. Some filters are assembled together with other components of the filtration system and then subjected to online wet heat sterilization or irradiation sterilization. Integrity must be checked before use.


4.Filling——Vial Filling Machine

1）Aseptic filling environment

Filling is carried out in a sterile environment and monitored in real-time using a suspended particle online monitoring system (including planktonic bacteria and settling bacteria). Isolation forms include RABS (Restricted Entry and Exit Isolation System) and Isolator (Isolator). A common form of isolation in sterile cleanrooms is the use of ORABS (Open Restricted Entry and Exit Isolation System), which has a background environment of Class B and an Isolator background of Class C/D. Regardless of which form is used to enter the sterile area, products, materials, items, etc. must undergo sterilization.

 


2）Filling process——Vial Filling Machine       

The filling process may seem simple, but it is actually a very complex process. The material of the filling needle, the size of the filling needle, the characteristics of the liquid, the length of the filling pipeline, if it is a peristaltic pump, the performance of the pump, the wall thickness of the silicone tube, and the setting of filling parameters, all may affect the accuracy of filling.


3）Stoppering & Capping——Vial Filling Machine

There are two types of stoppers for filling vial bottles: full stoppers and half stoppers, which are respectively suitable for water injection and freeze-dried preparations. The purpose of capping is to tighten the already pressed rubber plug at the bottleneck, thereby ensuring the integrity and sterility of the product for a long time. When capping, the capping machine applies a certain amount of pressure, causing the rubber stopper to deform. The rubber stopper is tightly integrated with the opening of the penicillin bottle, filling the gap between the rubber stopper and the vial bottle. The purpose of capping is not just to keep the rubber stopper from falling, but to seal it.