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USP 71

Nano-Test® > Research > Standards > USP 71

USP <71>

USP <71> is the general section on ‘Sterility Tests’ published by the United States Pharmacopeia (USP). This section defines reference methods for the detection of viable microorganisms in pharmaceutical products that must be supplied in a sterile state.

Harmonisation and relevant standards: This section is harmonised with EP 2.6.1 (European Pharmacopoeia) and JP 4.06 (Japanese Pharmacopoeia); the procedural principles, culture media and interpretation rules are largely identical. Sterility testing of medical devices is covered under ISO 11737-2 and in the context of sterilisation validation; USP <71> serves in particular as the basis for routine release testing of medicinal products. The appropriate framework must be selected depending on the product type and regulatory requirements.

Basic principle

Die Sterilitätsprüfung basiert auf der Feststellung, ob in einer bestimmten Menge des Produkts lebende Mikroorganismen vorhanden sind. Die Prüfung beweist nicht, dass das Produkt steril ist; sie bewertet vielmehr die Wahrscheinlichkeit einer Kontamination anhand eines bestimmten Probenahmeplans und einer bestimmten Methode. Daher sollten die Ergebnisse im Zusammenhang mit der Kontrolle des Produktionsprozesses, den Bioburden-Daten und der Sterilisationsvalidierung interpretiert werden.

Methods

USP <71> definiert zwei grundlegende Methoden:

  • Membrane filtration process: The product (or its solution) is filtered through a membrane with a pore size of 0.45 µm; micro-organisms are retained in the membrane, and the membrane is transferred to a suitable culture medium, or the culture medium is passed through the membrane. This is the preferred method for clear liquid products, water-soluble products, hollow-body products and washable products. For products containing antibiotics, it also enables the removal of inhibitory substances.
  • Direct inoculation method: The product is transferred directly into the culture medium and incubated. This method is used for products where membrane filtration is not possible (e.g. ointments, creams, certain suspensions).

There are additional guidelines for certain types of products: oily products, ointments, creams, aerosol and inhalation products, medical devices, transdermal systems, gases, etc. For these products, sample preparation (dissolving, emulsifying, neutralising, washing) is crucial to the applicability of the method.

The key parameters reported in the study are as follows:

  • Product description, monograph requirements and sampling plan
  • Sterility testing method used (membrane filtration or direct inoculation)
  • Culture media used (TSB, SDB or others) and incubation conditions (temperature, duration)
  • Sample size and sample preparation method
  • Results of the method suitability assessment / bacteriostasis and fungistasis test
  • Test microorganisms used and recovery data
  • Negative and positive controls and their results
  • Visual assessment and detection of bacterial growth following incubation
  • Results of microbial growth identification
  • Test result: Sterility test passed / failed
  • Edition of the USP-NF used and monograph reference
  • Data on measurement uncertainty and repeatability

Why is it carried out?

USP <71> wird für die folgenden wissenschaftlichen und regulatorischen Zwecke angewendet:

  • Pharmacopoeia compliance: Carrying out the prescribed sterility testing for products in accordance with the relevant monographs and ensuring they are suitable for sale on the US market
  • Ensuring patient safety: Assessment of contamination with living micro-organisms in sterile injectable preparations, ophthalmic preparations, infusion solutions and medical devices
  • Product release: Assessment of the sterility of production batches prior to market launch
  • Integration into sterilisation validation: Demonstration of the efficacy of sterilisation processes (in conjunction with ISO 11737-2, ISO 11135, ISO 11137, ISO 17665, ISO 14937)
  • Raw material and process control: Monitoring the microbiological status of raw materials, intermediate products and packaging components
  • FDA inspections and applications: Provision of sterility data for 510(k), NDA/ANDA, IND and BLA applications; demonstration of compliance with pharmacopoeias during inspections
  • Root cause analysis: A contribution to identifying the source of contamination in the event of a sterility failure
  • Evidence-based approach: Contribution to the comprehensive assurance of product sterility through data on bioburden (ISO 11737-1), endotoxins (USP <85>, EP 2.6.14), sterilisation validation and packaging (ISO 11607)

USP <71> does not, in itself, prove the sterility of the product; sterility is a measure of probability and is assessed in conjunction with the sterility assurance level (SAL). For pharmaceutical products, sterility testing should be carried out in conjunction with process control and sterilisation validation.

Als NanoTest führen wir Sterilitätsprüfungen gemäß USP <71> im Rahmen unserer akkreditierten Laborinfrastruktur und unseres Qualitätsmanagementsystems mit wissenschaftlicher Sorgfalt durch.

Für Informationen zur Methodenauswahl, Methodeneignung, Probenvorbereitung, Inkubationsbedingungen, zum Testzeitplan und zu den Berichtsprozessen für Ihre Sterilitätstests gemäß USP <71> können Sie sich gerne an NanoTest wenden.

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