Electron Microscopy Services - Our GMP certification

World's only GMP-certified TEM lab

We provide a complete GMP-certified transmission electron microscopy (TEM) analysis package that includes both negative stain transmission electron microscopy (nsTEM) and cryogenic transmission electron microscopy (cryoTEM) characterizations, each providing powerful image datasets, quantitative data, and conclusions from the analysis. Everything in our laboratory has been built for the purpose of TEM analysis in a GMP environment. Our TEM laboratory can be found at our headquarters in Stockholm, Sweden.

Application of GMP

The testing performed to our client's sample follows strict internal protocols as specified in our client project management procedures. Depending on our client's requirements, the data provided by Vironova can be produced at different GMP levels. All project documentation is recorded and archived to ensure process traceability, and all our critical equipment is calibrated and maintained.

Customer projects requiring GMP-certified facilities are:

Batch release testing
Stability testing
Testing to support client process and cleaning validation projects

Validating your method of analysis (MoA)

We provide a possibility to validate your method of analysis through a validation study. Validating your method of analysis assures the suitability of TEM as an analytical technique for assessing certain attributes of your product, and it assures the quality, reliability, and consistency of the results that are acquired through this technique.

GMP application to medicinal products

GMP applies to the manufacturing process for both medicinal products and investigational medicinal products (IMP) to ensure quality control.

ems-working-vironova-electron-microscopy-services-laboratory

Our equipment is calibrated and maintained.

All visitors of our GMP-certified laboratory are required to be logged before entrance.

Validate your method

We are a full service provider of validation studies.

Several regulatory authorities require that the method of analysis (MoA) should be validated for a drug product to be manufactured and to be introduced as a new drug into the market.

Our EMS facilities (BSLII)

In 2020, Vironova received a GMP certificate from the Swedish Medical Products Agency. Quoting the agency, Vironova is able to do:

"Testing with the purpose of characterization, evaluation, quality assessment and quality control of particles in micro and nanometer scale (drug substances, intermediate drug substances, drug products) using negative stain transmission electron microscopy (nsTEM) and cryogenic transmission electron microscopy (cryoTEM) with semi-automatic particle detection and analysis using software".