USP Harmonises Requirements on Sterile Water

GMP News No. 932: USP Harmonises Requirements on Sterile Water

GMP News
25 April 2007

USP Harmonises Requirements on Sterile Water

In the first supplement for USP 30, which will become effective on 1 August 2007, the requirements on sterile water for inhalation, sterile water for irrigation and sterile purified water regarding single ions and pH will be deleted and replaced by the sum parameter of conductivity.

In detail the requirements for ammonium, calcium, carbon dioxide, chloride and sulphate were deleted, just as the requirements for the not very meaningful pH value in purified water. The requirements with regard to pH, carbon dioxide as well as to the maximum concentration of further single ions are covered by the sum parameter of conductivity. According to USP paragraph <645> this will have to be conducted starting with step two – that means with measuring the conductivity after the absorption of atmospheric carbon dioxide. For containers with a nominal volume smaller than 10 mL, a conductivity of not more than 25 µS/cm is required, and for containers larger than 10 mL, not more than 5 µS/cm – each at 25  ±1 °C.

With this change, the US Pharmacopoeia harmonises the requirements regarding sterile waters with the requirements on purified water and water for injection, for which the sum parameter of conductivity replaced the requirements regarding single ions already in 1996.

Current and future USP requirements on water for pharmaceutical use are one of the main topics of the ECA conference "Pharmaceutical Water Systems – Maintaining High Quality" in Madrid, Spain, on 22-23 May 2007.

The second day of this combined conference deals with the No. 1 topic "Rouging" in pharmaceutical water systems.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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