Key Inspection Points for Vial Filling Capping Machine

2024-01-22

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Marya

The vial filling capping machine consists of a control system, bottle feeding system, filling system, capping system, etc. It is mainly used for filling and capping operations of non final sterilized products. This operation exposes the products to open air environment, which is a high-risk operation. To effectively reduce the risk of microbial contamination and minimize exposure to operators, the vial filling capping machine can be installed in a sterile isolation system.

The vial filling capping machine consists of a control system, bottle feeding system, filling system, capping system, etc. It is mainly used for filling and capping operations of non final sterilized products. This operation exposes the products to open air environment, which is a high-risk operation. To effectively reduce the risk of microbial contamination and minimize exposure to operators, the vial filling capping machine can be installed in a sterile isolation system.
The filling accuracy and stability of the vial filling capping machine are related to the difference in product filling volume. During the filling and capping process, environmental conditions, personnel intervention, and the inner packaging material itself can all carry particles and foreign objects, directly threatening the safety of the product. Therefore, during the inspection process, it is necessary to focus on the environmental conditions of filling and plugging operations, personnel intervention, etc. In addition, it is also necessary to check the file system, including the equipment verification report, to ensure the authenticity and completeness of the recorded content. During inspection, attention should be paid to the following aspects:

(1)The environment where the vial filling capping machine is located:

The cleanliness level of the functional room where the filling and capping machine is located should meet the requirements, and the maximum number of people to be accommodated during operation should be specified. The filling and plugging areas should be maintained with unidirectional flow to maintain the environmental conditions of the area. When inspecting, attention should be paid to the wind speed setting and environmental monitoring of the laminar flow system.

(2)Confirmation and verification of vial filling capping machine:

Filling and capping are high-risk operations, and the one-way airflow method should be verified to not cause pollution risks. During inspection, attention should be paid to the recording of airflow streamline testing, especially whether personnel intervention is representative: there may be situations such as bottle inversion, bottle sorting, power outage, and air conditioning system failure during the filling and capping process. During inspection, attention should be paid to the verification and implementation of failure modes; In addition, to reduce the risk of microbial contamination, the time limit of the filling process should be verified.

(3)Personnel operation risk:

Personnel are the biggest source of pollution, and during inspection, attention should be paid to the relevant job training, personnel changing, and personnel operation standards, especially the standardization of bottle pouring and bottle sorting.

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