Unrivaled breadth of analytical solutions, techniques and applications
Concept Life Sciences provides an unrivaled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical device, healthcare, agrochemicals, biocides, food and feed sectors, including pesticides. We specialize in the development, validation and deployment of highly sensitive robust analytical methods for the Occupational Hygiene (OH) monitoring of manufacturing and laboratory facilities.
Occupational hygiene
Occupational Hygiene is the discipline of anticipating, recognizing, evaluating and controlling health hazards in the working environment with the objective of protecting worker health and well-being. In practice, this means regular monitoring of active ingredients, relevant inactive ingredients, and surrogates via air filter sampling and surface swabbing, and analysis against agreed exposure limits using validated analytical methods.
Our holistic OH package includes the development and validation of analytical methods for multiple active ingredient types (hormones, cytotoxics, antibiotics, controlled drug substances):
- Support in OH risk assessment, limit setting, sampling/testing protocols
- Sensitive uHPLC-MS/MS methods to meet the growing demand for particularly challenging OEL / Reporting Limits
- Preparation and supply of media (swabs, filters, pre-loaded IOM cassettes); training of staff in sampling
- Routine analysis of samples to fast turnaround times
- Analytical method development, validation and testing of proprietary APIs as well as surrogate AI materials such as lactose, mannitol and naproxen sodium
GLP / GMP accredited laboratories
All work is performed within our MHRA & FDA-inspected, GLP / GMP accredited laboratories.
Our OH activities complement a range of other manufacturing support services to the pharmaceutical, healthcare and agrochemical industries including raw material and batch release testing, Out of Specification investigations, ICH stability and cleaning validation/verification. Our long history in pharmaceutical R&D and manufacturing support has resulted in over 500 validated HPLC methods for pharmaceutical actives.
Our capabilities
- GMP and GLP accredited; FDA inspected
- Analytical method development, verification, validation and transfer for uHPLC, Ion chromatography and other relevant techniques
- Wide range of relevant, highly sensitive detectors e.g. MS/MS, PAD
- Swab and filter recovery assessment and subsequent method validation
- Site visits for cleaning risk assessment and subsequent sampling
- Training of customer staff in swabbing techniques
