Antimicrobial & Preservative Efficacy Testing
Preservatives are added to multidose and aqueous healthcare products to protect patients from contamination every time a container is opened. Antimicrobial and preservative efficacy testing confirms that your formulation continues to control microbial growth over time, so you can release and maintain products with confidence.
Cormica provides antimicrobial efficacy testing to pharmacopeial methods such as USP <51>, Ph. Eur 5.1.3 and related BP and JP requirements, helping you meet global regulatory expectations while keeping patients safe.
Why antimicrobial efficacy testing matters
Even when preservative content is confirmed by chemical assay, it does not always guarantee effective microbiological protection. Antimicrobial efficacy testing (also known as preservative efficacy testing or antimicrobial effectiveness testing) challenges your product with defined microorganisms and assesses how well the formulation reduces or controls them over time.
This testing helps you to:
-
Demonstrate compliance with pharmacopeial requirements for multidose and aqueous products
-
Confirm that preservative systems remain effective during formulation development, stability studies and lifecycle changes
-
Reduce the risk of spoilage, loss of potency, and patient harm caused by microbial contamination introduced during use
At Cormica, this is directly linked to our mission: improving patients’ lives by providing comprehensive testing services that support safe, rapid product launch and release across the world.
Typical products tested
We support a wide range of pharmaceutical, medical device and healthcare products, including:
- Parenteral and injectable products
- Ophthalmic preparations and eye drops
- Oral liquids and syrups
- Topical creams, gels, lotions and ointments
- Nasal and other mucosal products
- Antacids and other aqueous OTC formulations
Get starting with AET & PET
To scope antimicrobial or preservative efficacy testing for your product, our team will typically discuss:
- Product type and formulation
- Container closure and pack size
- Intended markets and target pharmacopeias
- Development stage and any planned changes
From there, we will recommend an appropriate protocol, sample requirements and timeline so you can build antimicrobial efficacy testing into your development, stability or lifecycle plans.
Contact us to discuss your antimicrobial efficacy testing needs and how Cormica can help you move products to patients safely and efficiently.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Our Clients’ Experiences
