packaging Tag

19 Jun

Posted at 15:10h in Blog

In the issue of Pharmacopeial Forum PF 49(2) the proposed modification of the current version of the chapter USP <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants was published.

 

Proposed Revision of <1031>

The Packaging and Distribution Expert Committee (PDEC) proposes the following revisions to update and expand the scope of the current chapter:

  1. Change the title to “The Biocompatibility of Pharmaceutical Packaging Systems and Their Materials of Construction“.
  2. Expand the scope of the chapter to encompass plastic materials of construction and plastic and elastomeric components for pharmaceutical packaging/delivery systems and for packaging of combination products.
  3. Add an overview of the USP classification of plastics, which identified six different classes of plastics (Classes I–VI). A review of the utilization of the classification system found that typically only the most stringent category (Class VI) was used by suppliers of plastic materials of construction and components, and pharmaceutical manufacturers. This classification system has been replaced by the term “pharmaceutical grade polymeric materials“, which is defined as materials that are in compliance with specific in vitro tests.
  1. Include the following significant additions:
  • A risk-based approach to biocompatibility evaluation
  • Assessment of test methods
  • Chemical characterization as a key part of the overall safety assessment process
  • Biological reactivity test failure analysis
  • Overall biocompatibility evaluation
  1. Add sections for Glossary, Appendix, and References.

SOURCES:

The proposed USP General Chapter <1031> is available after registration to the Pharmacopeial Forum.

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31 Mar

Posted at 12:20h in Blog

As shortages of glass vials have been reported in the past years, to address concerns about the supply of such packaging materials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

Several official monographs in the USP-NF require the use of a specific glass type, for example “Type I glass” or “Type II glass.” Current General Chapter <660> Containers – Glass defines glass types by composition-based characteristics.

According to the general announcement, the revision of the monographs should provide some level of flexibility regarding the type of packaging by including a reference to a preferable type of glass for packaging, rather than prescribing a specific type of packaging material.

To address challenges, the proposed compendial revisions would include the following:

  1. Revisions to General Chapter <660> to remove glass classifications based on composition. Currently, <660> defines: Type I (borosilicate glass); Type II (treated soda-lime silica); and Type III (soda-lime silica). Under the proposal, General Chapter <660> would instead define glass Types I, II, and III by performance characteristics, allowing for additional compositions to be considered Type I, II, and III glass.
  2. Revisions to 14 monographs that currently prescribe a specific glass type by adding the word “preferably” in the packaging section of the monograph.” The addition of the word “preferably” to the monographs at issue means that the use of the glass specified is preferred, but not required. This proposed revision will give manufacturers additional flexibility in their choice of packaging and pave the way for new or different types of packaging to be approved.

 

Conclusions

To introduce more flexibility for manufacturers and regulators, the USP is therefore proposing the addition of the word “preferably” to the packaging and storage statements in the monographs that currently use prescriptive language. However, additional changes to many monographs may be needed to fully address the paradigm shift in defining suitable packaging materials for parenteral products.

SOURCES:

Notice of Intent to Revise: Proposal to Add Flexibility in the Selection of Suitable Packaging and Storage for Parenteral Drugs.

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