Sterile product analysis

We provide the following testing and analyses ensure your sterile products comply with the Pharmacopoeial standards.

Rapid Sterility Test in 5 days (Ph. Eur. 5.1.6)

Over the past 15 years, Confarma has built up extensive experience in sterility testing. The validation our Rapid Sterility Testing (RST) system means we can offer a technical innovation that is three times faster than traditional methods but also meets both regulatory and technical criteria.

Benefits of RST:

  • Release your batch in 5 days
  • Save storage costs
  • Increase analysis quality
  • Identify contaminants (non-destructive method)
  • Guarantee GMP conditions

Standard Sterility Test (Ph. Eur. 2.6.1, USP and JP 4.06)

We use three isolators specifically designed for consistent and reliable sterility testing. During the decontamination cycle, levels of hydrogen peroxide are controlled and monitored.

Pyrogen quantification (Ph. Eur. 2.6.30)

We have developed a method to quantify pyrogenic substances using an in vitro monocyte activation assay with a cell line of mature ‘Mono Mac 6’ monocytes. This advanced technique allows:

  • Quantification of all potential pyrogens, whether from bacteria, viruses, animals, or materials
  • Ethical protection of laboratory animals
  • Quantitative results in 48 hours

Bacterial endotoxin testing (Ph. Eur. 2.6.14, USP)

We can detect and quantify endotoxins using the following testing methods:

  • Gel clot: limit test or semi-quantitative (Method A & B of the European Pharmacopoeia)
  • Turbidimetric kinetic (Method C of the European Pharmacopoeia)
  • Colorimetric Kinetic (Method D of the European Pharmacopoeia)
  • Recombinant Factor C (alternative method)

Bioburden (Ph. Eur. 2.6.12, USP)

Bioburden analysis before sterilization is a critical control point to limit risks during the sterilisation process and includes:

  • Aerobic microbial species
  • Anaerobic microbial species

Testing is performed within our microbiology laboratory in class A (ISO 5) laminar flow hoods, which are regularly assessed to ISO 14644 standards to assure the highest levels of security.

Non-visible particles (Ph. Eur. 2.9.19, USP <787>, <788>, <789>)

‘Invisible’ undissolved and moving particles can cause unintentional contamination of injectable and infusion preparations. Their presence indicates a fault in the manufacturing process which introduces a risk to patients, if left unchecked. We analyse non-visible particles by the two official methods:

  1. Counting non-visible particles by blocking light
  2. Counting non-visible particles by microscopy

Microorganism identification

Where a critical contamination has occurred e.g. media preparation or positive sterility test, we can provide microbial genotyping to identify the causative agent.

Mycoplasma qPCR (Ph. Eur. 2.6.7.)

Mycoplasmas are known to be occasional microbial contaminants of cell cultures that produce biologics. Nucleic acid amplification techniques (NAT) is used as an alternative to one or both of the other methods after suitable validation.