USP Draft Chapters on Glass Containers <660> and <1660>

The USP Packaging and Distribution Expert Committee is proposing the revision of the USP glass container chapters <660> Containers-Glass and <1660> Evaluation of the Inner Surface Durability of Glass Containers.

The drafts of these two chapters have been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.

The revision of <660> is proposed "to clarify the intent of the chapter and provide additional information to aid in the execution of the Surface Glass Test, Glass Grains Test, and Surface Etching Test".

USP says that "none of the proposed revisions will change the chapter's requirement. However, there will be a revision proposal in 2018 that is meant to modernize tests, test methods, and specifications within the chapter, and will be a high-impact revision".

Listed below are the key changes being proposed for <660>: 

  • The chapter title has been changed to “Glass Containers Used in Pharmaceutical Packaging/Delivery Systems”;
  • A Scope section has been added;
  • Table 1 and Table 2 have been consolidated into one table which denotes the specifications for the Surface Glass Test, Glass Grains Test, and Surface Etching Test for a glass container to be classified as Type I, II, or III;
  • Additional requirements for the autoclave used for the various tests have been added to the chapter;
  • The list of ancillary equipment required to execute the chapter has been expanded;
  • The Purified Water requirement has been aligned with the Ph. Eur. General Chapter 3.2.1 "Glass Containers for Pharmaceutical Use";
  • Additional information on the autoclaving procedure has been added to the chapter, including Reference temperature curve, autoclave calibration, and routine autoclave runs (see also Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use");
  • Additional information on how to titrate the test and blank samples has been added to the chapter.  

Additionally, the Expert Committee is proposing the revision of <1660> to "clarify the intent of the chapter and provide additional information to aid in the understanding of the factors that affect the inner surface durability of a glass container".

Listed below are the key changes being proposed to <1660>:

  • The chapter title is changed to “Glass Containers Used in Pharmaceutical Packaging/Delivery Systems: Manufacture and Evaluation of the Inner Surface Durability”;
  • The Purpose section is changed to an Introduction;
  • Table 1 is added to include aluminosilicate glass;
  • The Glass Surface Chemistry section is revised and new equations added;
  • A new section is added on Glass Particles and Flakes;
  • A new section is added on Glass Delamination including a clarification that examinations regarding Delamination are intended to be conducted by the pharmaceutical manufacturer, not the glass manufacturer or converter;
  • New sections are added on Critical Parameters in the Autoclave Loading Procedure, Trays, Autoclave Loads, Sample Types and Sizes, and Autoclave Calibration and Load Mapping. 

Furthermore, minor editorial changes have been made to update the two chapters to current USP style.

A workshop on Modernization of USP Packaging Standards for Glass and Elastomeric Components, will take place from June 19–20, 2017 at the USP Meetings Center in Rockville, Maryland, to discuss these two proposals.

The USP also provided a briefing list in PF 43(3) which includes monographs and/or chapters that both reference the general chapters under revision and require revision to keep references to the General Chapter accurate. The USP says that "other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles".

Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <660> and <1660>.

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