Are you still missing your instrument calibration due dates?

01/10/2026

PETra’s Instrument Performance Test automates equipment qualification and calibration for GMP radiopharmaceutical manufacturing

Maintaining the qualification, calibration, and ongoing performance of instruments used in the synthesis and testing of radiopharmaceuticals is critical. Particular emphasis should be placed on batch records documenting the status of major equipment used throughout production and QC.

PETra’s Instrument Performance Test (IPT) module is allowing manufacturers to effectively manage the qualification and calibration of instruments and other equipment to satisfy regulatory requirements.

Replacing paper records and manual checks

PETra’s IPT is compatible with all instruments including HPLCs, TLCs, gamma spectrometers, GCs, pH meters, dose calibrators and more. Each of these requires periodic qualification, calibration, maintenance or routine performance testing. Historically, this has been dependent upon manual procedures using paper records, logbooks and spreadsheets, which is laborious and prone to human error.

PETra simplifies these processes by allowing users to scan an instrument labelled with a barcode to instantly generate key instrument details ahead of production or testing, including:

  • Qualification dates
  • Calibration expiry dates
  • Instrument status
  • Responsible personnel
  • Associated testing requirements

Keeping instruments calibrated and qualified

One of the greatest challenges in maintaining GMP compliance is ensuring that instruments remain within their approved calibration and qualification periods. PETra notifies users of upcoming qualification, calibration and maintenance activities. Users receive reminders on a monthly, weekly and daily basis before due dates, allowing sufficient time to plan and complete required actions.

PETra also automatically verifies instrument status whenever equipment is selected for use. If a calibration has expired, the LIMS alerts the user and prompts them to determine whether a deviation should be raised before proceeding. If an instrument has failed, PETra can prevent its use entirely.

These safeguards help eliminate common compliance risks, such as overlooking calibration deadlines or using equipment that no longer meets qualification requirements.

Managing GMP environments and cleanrooms

Although originally developed to manage equipment qualification and performance testing, many existing PETra users have expanded the use of the IPT module to other items subject to periodic inspection, testing or routine scheduling. This includes equipment such as pipettes, and even cleanrooms and manufacturing facilities.

Some organisations use the IPT module to manage daily, weekly, monthly and annual cleaning schedules for GMP environments. Using barcode-based tracking and automated reminders, PETra can notify personnel when cleaning activities are due, helping ensure important housekeeping and environmental monitoring tasks are completed on time.

A single barcode can be associated with multiple schedules simultaneously, creating a flexible framework for managing recurring activities throughout a facility.

Request a guided demonstration

You can learn more about PETra’s IPT module and other features by clicking the button below to speak to a product specialist directly to request a guided demonstration.

REQUEST DEMO

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