Further US-EU harmonisation increases emphasis on delamination


The latest revisions, USP 38-NF33 and Ph. Eur. 8.3, further emphasise recommendations for propensity and stability studies

According to independent research and development, consultancy and testing facility, Glass Technology Services (GTS), the latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging include further harmonisation in terms of testing requirements and an increase in the need for delamination propensity studies across the pharmaceutical supply chain.

Commenting on the latest test method revisions for pharmaceutical glassware, including bottles, vials, ampoules, cartridges and syringes, GTS Laboratory Manager, Daniel Capon, said: ‘The United States (USP) and European (Ph. Eur.) Pharmacopoeias remain the most widely used in the global market, and recent revisions to both monographs continue to harmonise requirements between the two — bringing welcome simplification and, in some cases, savings for customers that regularly test according to both the USP and Ph. Eur. standards.’

‘The latest revisions, USP 38-NF33 and Ph. Eur. 8.3, further emphasise recommendations for propensity and stability studies, with direct references now being included in both USP <660> and Ph. Eur. 3.2.1 for the first time,’ he said, adding: ‘This is a key concern for many drug manufacturers looking to approve their products in the EU and US, and we have seen a dramatic increase in global companies coming to us for advice, consultancy and study programmes. Being such a specialist area, it is understandable that there is so much concern and uncertainty; we are one of only a few laboratories that hold the necessary specialist glass knowledge, experience and equipment.’

Key changes include:

  • direct reference to the recommendation for delamination propensity or evaluation studies within both USP <660> and Ph. Eur. 3.2.1 for the first time
  • stricter autoclave programmes within respective glass grains and surface tests across both monographs, with additional requirements for the time-temperature profiles that must be achieved during sample heating/cooling and the required use of external thermocouples for temperature logging
  • mechanical sieve-shakers/sieving machines now allowed in glass grain preparation in both the USP and Ph. Eur.

Capon explains: ‘This ongoing harmonisation is another positive step forward and builds on the significant unification between USP 37-NF32 and Ph. Eur. 8.0 in 2014, which saw the USP adopt the Ph. Eur. glass grains and surface tests.’

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‘The key concern for many pharmaceutical and medical companies comes down to the growing need for glass surface delamination evaluation, propensity and stability studies. This has been a key area of support and development for us in recent years – with a range of services available and our direct involvement in research groups, including the International Commission on Glass’ Technical Committee, TC12, for glass delamination.’