Many manufacturers rely on robust and suitable packaging to deliver their products to the end consumer in prime condition. Failed or faulty packaging results in a substandard, damaged product, leading to dissatisfied customers, a damaged reputation and loss of business.
Therefore, most manufacturers implement regular testing procedures to ensure standards are met. The manufacturer can quite often check for non-compliance by testing the first-off production, which allows for fine-tuning of the process to ensure seal integrity before going into full production. Seal integrity testing provides a visual way of ensuring the correct machine setup and that the film changes are properly installed to reduce the risk of faulty seals and potential leaks.
Manufacturers are also regularly audited by customers (such as major high street supermarkets), so it is looked upon favourably if seal integrity and leak testing records are in place.
Good Manufacturing Practices
In the UK and Europe, specific guidelines for testing seal integrity and leak detection in packaging vary depending on the industry and product type. However, manufacturers often follow general principles and standards to ensure product safety and quality. Known as Good Manufacturing Practices (GMP), they are employed by manufacturers to maintain the quality and integrity of their products. The GMP are guidelines and standards that have been developed and enforced by various regulatory bodies around the world.
Pharmaceutical Products
In Europe, the European Medicines Agency (EMA) and the European Commission are involved in the development and implementation of GMP guidelines for pharmaceutical products.
While GMP guidelines do not specify the frequency of checking for packaging leaks and seal integrity specifically, they do emphasise the importance of regular inspections and implementing appropriate quality control measures.
GMP guidelines contain a requirement to perform a product quality review (PQR). The PQR is expected annually, although timeframes can be adjusted and should be documented in a Standard Operating Procedure.
Food Industry
In addition to GMP guidelines, the food industry must comply with specific regulations or standards that address packaging integrity. The British Retail Consortium (BRC) Global Standards and the International Featured Standards (IFS) provide guidelines and requirements for packaging quality and integrity. These standards often outline the need for regular checks on packaging integrity, but the frequency varies depending on the product.
The British Retail Consortium Global Standards
The British Retail Consortium is globally recognised across both food and non-food categories and operates the most rigorous third-party certification scheme of its type.
The Global Standard for Packaging Materials provides a common basis for the certification of companies supplying packaging to food producers and is regularly updated to reflect the latest developments in product safety. It provides a robust framework to assist packaging manufacturers in producing safe packaging materials.
The Standard requires companies to implement a programme of internal audits to ensure product safety, integrity and quality. The frequency should be established in relation to the previous audit performance but must be conducted at least annually.
International Featured Standards
The IFS PACsecure Standard assesses packaging material manufacturing and converting processes concerning product safety, quality, and customer and regulatory compliance. The Standard is applicable for the production, processing or conversion of packaging components and materials intended to be used as primary or secondary packaging in food, as well as in cosmetics and personal care products, including:
- Flexible plastic
- Rigid plastic
- Paper and board
- Metal and alloys
- Glass and ceramic.
Benefits of IFS PACsecure certification include reduced operating costs, continuous improvement and demonstrating commitment to product safety and quality, which can increase sales.
IFS-approved auditors assess companies to evaluate compliance using a scoring system. Once certified, businesses are subject to mandatory unannounced audits every three years. However, internal audits critical to product safety must be completed at least once per year.
This audit should cover all requirements of the IFS PACsecure Standard, which involves conducting a hazard analysis and risk assessment based on legal and regulatory requirements, good manufacturing practices (GMPs) and industry guidelines.
The hazard analysis and risk assessment is broad in scope and should cover all raw materials, wrapping materials and production processes throughout the product life cycle.
A full description of the product must exist, comprising its composition, characteristics, legal requirements, methods of treatments, durability, wrapping and labelling, conditions for storage and more.
Companies must also determine and record critical control points (CCPs) — such as leak detection — and establish monitoring procedures to maintain control.
The hazard analysis and risk assessment should be verified annually at a minimum. However, a new analysis should be carried out for new products or the existing risk assessment reviewed when an existing product or production process is modified.
A complete internal audit checklist is available from IPS PACsecure. The checklist includes specific guidelines for packaging compliance, with companies required to verify the suitability of the material used by means of sensory tests, chemical analyses, functional tests, storage and distribution tests, and migration test results. This process may include seal integrity or leak detection testing to ensure that the packaging material has no negative impact on the product and minimises the risk of cross-contamination.
Further, the Standard requires a traceability system to identify products and test results. This system must be tested on a “periodic” basis — at least once a year.
It is important to note that GMP guidelines are continually evolving and subject to updates and revisions as new technologies, scientific knowledge and regulatory requirements emerge. Therefore, it is essential for manufacturers to stay updated. Our LIMAB product specialists are always on hand to help.
Seal integrity and leak detection testing is a proactive approach to prevent leaks, contamination and potential risks. Implementing a testing frequency plan and documenting results will ensure the integrity of product seals throughout their lifecycle and provide quality assurance to product manufacturing.
Learn More about Leak Detection and Seal Integrity
Seal integrity testing is pivotal in protecting against leaks or defects and ensuring packaging is safe and effective across multiple use cases and industries. Learn more about leak detection methods and applications by using the links below:
- Learn more about leak detection and seal integrity testing and why it is important
- Learn more about the methods of leak detection and seal integrity testing available
- Learn more about burst, bubble emission and altitude simulation package seal integrity testing
- Learn more about force decay, seal strength and vacuum decay testing
- Learn more about dye penetration seal integrity testing
- Learn more about flow rate seal integrity testing
- Learn more about how to select the right leak detection and seal integrity method for your business
- Learn more about how documents and records of seal integrity testing can be stored.
Explore Our Range of Leak Detection and Seal Integrity Testing Equipment at LIMAB UK
Our team of product specialists at LIMAB UK get to know the unique needs of your business and provide one-to-one support to find the best package leak detection and seal integrity testing method for you. Request a consultation today by calling +44 (0)1823 668633, emailing hello@limab.co.uk or submitting a contact form.
