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Why do veterinary vaccine polypropylene bottles need ISO15378 certification?

Sep. 09, 2024

In the field of veterinary medicine, the safety and effectiveness of vaccines are directly related to the health of animals and the stability of the breeding industry. In order to ensure that these vaccines are not contaminated during transportation and storage, polypropylene bottles for veterinary vaccines play a vital role. Polypropylene bottles are widely used in the packaging of veterinary vaccines and vaccine diluents due to their superior chemical stability and durability. In order to ensure the quality and reliability of these packaging materials, ISO15378 certification has become a key quality standard.

Specification and material introduction of plastic vaccine bottle

250ml PE plastic vaccine bottle

1. The role and requirements of polypropylene bottles

Polypropylene bottles for veterinary liquid vaccines are mainly used to package various veterinary inactivated vaccines and vaccine diluents. Since the effectiveness of vaccines depends on the stability of their ingredients, the quality and safety of packaging materials directly affect the final effect of vaccines. The following are some basic requirements for packaging quality:

1. Chemical stability: Polypropylene materials need to be stable to the ingredients in the vaccine, without chemical reactions or release of harmful substances.

2. Physical properties: The container should have sufficient strength to withstand the physical pressure during transportation and storage, and not be easily damaged or deformed.

3. Sealing: The sealing of the bottle is crucial, and it is necessary to effectively prevent the vaccine from being contaminated during storage and use.

2. The importance of ISO15378 certification

ISO15378 certification is a quality management system certification specifically for packaging materials that come into direct contact with drugs. This certification is based on the ISO 9001 quality management system standard issued by the International Organization for Standardization (ISO), and combines the special requirements of drug production to develop a set of quality management specifications for drug packaging materials. The core elements of ISO15378 certification include:

1. Risk management:

Establish a sound risk management mechanism: ISO15378 certification requires manufacturers to conduct comprehensive risk assessment and control of all aspects of packaging material design, production and inspection. This measure is intended to ensure that packaging materials do not cause contamination or cross-contamination to vaccines and protect the purity and safety of vaccines.

2. Traceability:

Ensure the traceability of the production process: From the procurement of raw materials to the delivery of the final product, every step needs to be recorded in detail. This not only helps to quickly locate the cause when a problem occurs, but also takes effective corrective measures to ensure the continued stability of product quality.

3. Safety:

Compliance with laws, regulations and standards: ISO15378 certification emphasizes the safety of packaging materials and requires that packaging materials must comply with relevant laws, regulations and standards to ensure that they do not cause harm to human health. In addition, the design of packaging and labels must also comply with regulations to ensure the correct use and storage of vaccines.

Specification and material introduction of plastic vaccine bottle

100ml PP vaccine vial

ISO15378 certification ensures that packaging materials will not contaminate vaccines and ensure the overall quality and safety of vaccines through quality management of polypropylene bottles for veterinary liquid vaccines. This is essential to protect animal health and ensure that vaccines can maintain their expected effects throughout their entire life cycle. Passing these certifications not only enhances the competitiveness of enterprises, but also promotes the progress of the entire industry and ensures the protection of animal health.


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