BillerudKorsnäs explains global standards for medical packaging

Photograph - Billerudkorsnäs

On xi November 2020, Billerudkorsnäs organized a webinar providing a quick and understandable overview of the ISO 11607 standard. Afterwards introducing ISO 11607, Radhika Peterson, regulatory affairs manager, and Jonathan Andrews, business development manager Medical at Billerudkorsnäs, presented an overview of the company and case studies explaining the significance of standards compliance.

Medical paper past Billerudkorsnäs

Sweden headquartered Billerudkorsnäs, with a turnover of SEK 24.iv billion (approximately Rs 21,000 crore), owns eight newspaper mills – 6 in Sweden, and one each in Finland and the UK. The company is highly rated by the Dow Jones Sustainability Indices.

BillerudKosnas manufactures medical papers at two mills – Beetham (United kingdom of great britain and northern ireland) and Skärblacka (Sweden). Equally Andrews explained, "The company has multiple production sites for medical papers and a very broad range of medical packaging papers. It has decades of experience and deep knowledge of the market requirement. . . The two mills independently developed medical packaging papers many years agone before meeting in 2004. Their legacy production ranges combine to form a truly all-encompassing catalog."

The Beetham mill began producing medical paper in the tardily 1960s, specializing in the UK ministry of defense requirements. Today, 50 years later, information technology is the home of Billerudkorsnäs steam sterilizable grades, advanced direct seal, and reinforced papers.

Billerudkorsnäs' Skärblacka mill has produced papers for medical device packaging since the 1980s. It makes cost-constructive straight seal papers for thermoform-fill and seal applications and lightweight, make clean papers for applications such every bit surgeon'due south gloves inner wraps.

Standards – Why we need them

Peterson believes that in that location are many good reasons to use standards – "We may non exist aware of them, only we use standards every 24-hour interval. A standard is a keen mode of making a product, managing the procedure, or even delivering service. Standards help us ensure safety and atomic number 82 to a amend quality of production and service and thus happier customers. Ofttimes, we all recognize standards every bit testing methods because standards contain requirements and recommendations."

Mandatory vs Voluntary

According to Peterson, regulations and directives are mandatory for businesses. However, information technology is non obligatory to comply with standards. Standards remain voluntary. She added, "A standard is an fantabulous tool to testify compliance with an appropriate function of a directive. You tin can utilize the same testing procedure equally your client, ensure safety and reliability, ensure production quality, and use common nomenclature." Peterson explained the relevant types of standards as:

• Harmonized standards for the presumption of conformity with regulation or directive, for example, ISO 13485 and ISO 10993
• Standards are referred to equally horizontal and vertical standards based on their applications. For case, ISO 11607 is a horizontal standard applicable for all types of materials, packaging, and related medical devices. Vertical standards, on the contrary, utilize to a particular area, industry, or procedure – for case, EN 868 is related to specific materials used for medical packaging.
• Test methods draw the testing methodology, what to exam, how to test, and how to report the results, for example, ASTM, DIN, EN, ISO, and Tappi. The technical specification does not accept the same high dignity, such equally ISO/TS 16775.

"Standards are also referred to as horizontal and vertical in their applications. Information technology is very of import ever to have the latest version as the revision can differ significantly," she added.

Standards used for medical packaging

After a cursory introduction about the standards used for medical packaging, Peterson presented two case studies where the lack of compliance led to consequences. "In one case, the packaging caused an infection problem in the hospital. The investigation showed that no integrity test was washed during validation. If the standardized integrity test ASTM 1929 blue dye had been used, production quality could have been ensured. Therefore, it is important to use a exam according to the scope of the method."

The 2nd case emphasized the need to consider all essential factors such as sterilization, the packaging line, and others. "If both parts of ISO 11607 had been considered in the design procedure, the validation would be finalized."

Why use ISO 11607?

It is recommended to use the standard equally a ready tool for compliance requirements. There are plenty of reasons to use ISO 11607 – to ensure the integrity of the packaging, rationale behind each acceptance criteria, and because the worst-case scenario to develop technical files and protocols. The standard considers all aspects of the packaging design, such as cloth backdrop, converting files, sterilization – the whole packaging system.

Formal approval of the process validation is needed. Peterson added, "The documentation shall summarize and reference all protocols, resource and land conclusions regarding the validation status of the process. It should include procedures to ensure that the packaging production process is under control and within the established parameters during routine operation.

"The sterile barrier organization shall exist assembled nether appropriate conditions to minimize the take a chance of contagion. Specified process variables shall be routinely monitored and documented."

Key takeaways

Concluding the webinar, Andrews reiterated the primal takeaways of the webinar, proverb, "Medical packaging is almost as important every bit the device itself. You should contact your cloth supplier for the supporting data. Standards are our friends, non enemies. They brand your life easier when testing, evaluating, and validating. However, information technology is of import to continue runway of the latest reversion or revision of the standard to avert problems."

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