What is MALDI-TOF?

MALDI-TOF stands for Matrix-assisted Laser Desorption/Ionisation Time of Flight, a mass spectrometer capable of identifying microorganisms at the species level.

It uses an ultraviolet laser to irradiate samples embedded in a matrix, inducing the acceleration of proteins and peptides. This acceleration enables them to travel towards the detector at a speed dependent on their mass.

Given that proteins and peptides have distinct masses, they reach the detector at different times. Subsequently, this speed is translated into an exact molecular mass, which is then compared with an internal database of microorganisms.

The MALDI-TOF can allow quick turnaround times, it has the capacity to test up to 95 samples per plate, with the capability of testing more than one plate per day, covering organisms such as, but not limited to:

  • Micrococcus luteus
  • Escherichia coli (E. Coli)
  • Staphylococcus aureus
  • Bacillus subtilis
  • Pseudomonas aeruginosa
  • Salmonella enterica
  • Candida albicans

The new instrument delivers precise results and swiftly identifying organisms with high accuracy — particularly crucial in light of the significant updates to EudraLex Annex 1 (Manufacture of Sterile Products) in August 2023.

Outline of Annex 1 Changes

Implementation of Contamination Control Strategy (CCS):

Operating in the pharmaceutical, cleanroom, or sterile manufacturing industries now mandates the implementation of a Contamination Control Strategy (CCS).

Vital Role of Viable Environmental Monitoring:

A crucial component of CCS involves viable environmental monitoring, aiming to prevent contamination in the final product.

Regular Review and Trend Analysis of Environmental Monitoring Data:

Environmental Monitoring data must be regularly reviewed and analysed. This includes the analysis of microorganisms recovered within a facility, making Microbial Identification essential for maintaining a contaminant-free environment.

Therefore, the updates to EudraLex Annex 1 in August 2023 have reinforced the necessity for precise microorganism identification in the pharma sector. Tentamus Pharma UK's MALDI-TOF addresses these changes by ensuring:

  • Identification of microorganisms to the species level.
  • Adherence to the revised Annex 1 mandates for enhanced quality control.
  • Alignment with pharma industry standards, upholding the highest levels of product integrity in sterile product manufacturing, such as medical equipment.

This revolutionary advancement positions Tentamus Pharma UK as a true ambassador in delivering Good Manufacturing Practices, aiming to assist our partners and friends in meeting the regulatory requirements outlined in the updated Annex 1. We offer pharmaceutical companies an innovative solution for quality control processes.

Key Benefits for Clients and Partners

  • Swift and accurate analysis with MALDI-TOF, a sophisticated mass spectrometer.
  • GMP laboratory.
  • High throughput with the capacity to analyse 95 samples per plate in under one hour.
  • Multiple daily analysis sessions, ensuring efficiency in pharmaceutical testing.
  • Fast Turnaround Time: Results delivered within 24 hours.
  • Committed to excellent customer service and tailored support.
IMG 8234 (1)

Advancements in Sterile Product Manufacturing:

In the context of sterile product manufacturing, where adherence to stringent regulations is paramount, MALDI-TOF's ability to identify microorganisms to the species level represents a significant leap forward. Tentamus Pharma UK ensures that pharmaceutical companies meet the updated Annex 1 requirements, maintaining the highest levels of product integrity.

Prompt Assistance for Your Testing Needs

Our dedicated team is ready to assist you promptly in harnessing the power of MALDI-TOF applying GMP practices and standards for your all pharma testing requirements. Please feel free fill out the contact form, and we will get in touch in no time!

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