ANALYTICAL SERVICES for human and veterinary medicinal products
Our analytical service portfolio covers a wide range of chemical and microbiological services. We are continuously developing our laboratory environment towards fully electronic data management, which continues to secure the integrity of analytical raw data, in compliance with the latest regulatory requirements. This, together with constant investments in our laboratory techniques and facilities, ensures that we can keep up with the needs of our clients and the continuous industry development.
By selecting Medfiles as your partner, you can be sure that your medicinal product meets the requirements set for its manufacture and quality control.
Over 30 years of experience in analytical tasks
70+
experts
2900+
chemical analyses in 2023
4000+
microbiological analyses in 2023
50+
clients in 2023
Quality control analytics
Medfiles has more than 30 years of analytics experience in accordance with the Japanese, European and US pharmacopoeias as well as in the quality control analysis of drug products. Our service portfolio covers:
- Comprehensive quality control analytics of drug substances, finished products, excipients and packaging materials
- Re-analysis of medicinal products for the EU market
- Batch certification by a Qualified Person (QP)
Inhalation analytics
Our humidity- and temperature-controlled GMP-certified laboratory is ideal for performing analytics for inhalation drug products in the required conditions. We have extensive experience in the analytics of dry powder inhalers (DPIs), metered-dose inhalers (MDIs) and nebulisers. When the analytics of inhalation drug products must be performed in extreme conditions, our enclosure system allows regulating the surrounding conditions in the temperature range of 17 to 35 °C and relative humidity in the range of 17 to 85 % RH.
Our service portfolio includes, among others, the following analytical techniques for inhalation drug products:
- Determination of aerodynamic particle size with the following equipment:
- Next Generation Impactor (NGI)
- Multi-Stage Liquid Impinger (MSLI)
- Determination of delivered dose uniformity
INHALATION ANALYTICS IS OUR CORE COMPETENCE
- 800 inhalation samples analysed in 2023
- Temperature- and humidity-controlled laboratory of 450 m2
- Team of 40 experts
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS
Our method development and validation team has more than 25 years of experience in working with approaches compliant with the ICH and FDA guidelines. This service can be performed separately or as a part of your formulation development project. Over the years, we have assisted more than 60 clients in 300 projects.
Our service portfolio includes:
- Method development, validation and transfer with full documentation
- Development and validation of analytical methods for cleaning validation
- Risk-based verification tests for pharmacopoeia methods.
Mikrobiological services
Our GMP-certified microbiological laboratory provides versatile analytical and consultation services, for example for environmental monitoring. Microbiological analyses are performed according to the current pharmacopoeias. Our services include:
- Determination of total aerobic microbial count and amount of yeast or mould (TAMC/TYMC)
- Testing for specified microbes
- Determination of preservative efficacy
- Validation of test methods and complete documentation
- Growth promotion testing of microbiological culture media
- Comprehensive testing of biological indicators, such as efficacy of sterilisation and spore testing
- Hygiene controls
- Microbiological assay of antibiotics.
TECHNIQUES FOR CHEMICAL AND PHYSICAL TESTING
- UHPLCs with UV and PDA/DAD detectors
- HPLCs with UV, PDA/DAD and RI detectors
- GC with head space, FID detector
- FTIR (FT infrared spectrometer)
- Spectrophotometer
- Polarimeter
- Titrators
- In vitro dissolution
- Disintegration tester
- Friability tester
Team
Our staff of experienced professionals have the required training and qualifications to work under the GMP quality guidance, taking great pride in the accurate and scientifically valid results they provide. Through continuous training of our staff, we make sure that we can always provide high-quality services to our clients. We are continuously developing our operations, taking into account our clients’ needs and the applicable regulatory requirements.
Clients
Our team serves businesses in the pharmaceutical sector around the world. Client satisfaction and trust are of paramount importance to us.
“Cooperation with Medfiles has been great. The response times are quick, and the staff is always ready to help. Our requests are always met – even within tight schedules – which we highly appreciate.”
– A Finnish pharmaceutical manufacturer
