Monitoring Exposure to Active Pharmaceutical Ingredients and Cytostatic Agents to Improve Workers Protection
The pharmaceutical industry, health facilities, and laboratories handle chemical compounds and active pharmaceutical ingredients with specific toxicological properties on a daily basis. Controlling occupational exposure to these substances is a major occupational health challenge for both production workers and healthcare and technical staff. Thanks to the expertise of our subsidiary Toxilabo, which specializes in industrial toxicology and occupational health, TERA Environnement supports its clients in assessing and monitoring exposure to pharmaceutical active ingredients and cytostatic drugs.
Active Pharmaceutical Ingredients and Cytostatics: What Are They?
Active pharmaceutical ingredients are the substances responsible for a drug’s therapeutic effect. They may be present in the form of powders, liquids, or aerosols and are handled during numerous processes: synthesis, production, packaging, quality control, hospital preparation, and even the disposal of pharmaceutical waste.
Chronic exposure to certain active ingredients can, over the long term, lead to accumulation in the body and potential health effects. For this reason, monitoring, assessing, and controlling occupational exposure to these substances is a key concern in work environments where they are handled.
Among these compounds, cytostatic drugs hold a special place. Used primarily in cancer treatments, these cytotoxic drugs act on the cell cycle. However, their effects are not limited to tumor cells; they can also affect healthy cells. The risks therefore extend not only to patients but also to healthcare professionals who may be exposed during the manufacturing, preparation, administration, or cleaning and maintenance of these drugs.
Why analyze active ingredients in the air and on surfaces?
Effective chemical risk management depends first and foremost on a precise understanding of workers’ exposure levels.
Measuring active pharmaceutical ingredients and cytostatic drugs in workplace air helps identify potential emissions during production, weighing, transfer, or packaging operations… Certain cytostatics, such as cyclophosphamide, 5-fluorouracil, and ifosfamide, can be found in the air of work environments when they are being handled.
Surface swabs, on the other hand, are used to assess residual contamination on equipment, work surfaces, isolators, or other sensitive areas. They are a particularly useful tool for verifying the effectiveness of cleaning and decontamination procedures.
These measures serve several purposes:
- assess employees’ occupational exposure;
- verify the effectiveness of containment systems;
- approve collective and individual protective equipment;
- monitor the quality of cleaning procedures;
- confirm the absence of residual contamination after decontamination;
- document procedures for the prevention and management of chemical risks.
In certain situations, these investigations may be supplemented by biological tests to provide an even more comprehensive picture of occupational exposure.
Toxilabo: Industrial Toxicology Expertise to Support Your Projects
A subsidiary of TERA Environnement, Toxilabo is a laboratory specializing in toxicology, industrial hygiene, and the assessment of occupational exposure. For more than twenty years, its teams have been assisting manufacturers, healthcare facilities, occupational hygienists, inspection agencies, occupational physicians, and occupational safety departments in France and internationally with managing chemical risks.
The laboratory is one of the few French facilities capable of working simultaneously on:
- workplace air testing;
- surface analyses;
- laboratory tests (urine, blood);
- analytical development projects led by our Research & Development division
This comprehensive expertise enables us to provide a coherent and tailored response to the challenges faced by both pharmaceutical companies and healthcare facilities.
A comprehensive range of products dedicated to active pharmaceutical ingredients
To meet the diverse needs of its clients regarding the measurement of active ingredients, Toxilabo offers several levels of support.
The laboratory already has an extensive catalog of active ingredients that can be analyzed on a routine basis using methods developed and validated in-house. More than 80 substances are thus already available for analysis in workplace air.
When a company already has an analytical method developed in-house or by another laboratory, Toxilabo teams can handle the transfer, validation, and implementation of that method within the company’s laboratory.
For innovative molecules or active ingredients not yet listed in the laboratory’s catalog, Toxilabo draws on the expertise of its Research & Development division to design and validate dedicated analytical methods. These methods are custom-developed, taking into account the molecule’s physicochemical characteristics, its EOB (Occupational Exposure Band) level, the target concentrations to be measured, and the project’s specific objectives.
See below for a list of active ingredients that can already be analyzed in our laboratory
List of active ingredients already available and the CAS number associated with each compound
3-Methoxyandrostadienone – CAS : 57144-06-6
9-alpha-hydroxyandrostenedione – CAS : 560-62-3
Chlormadinone acetate – CAS: 302-22-7
Dexamethasone acetate – CAS: 55812-90-3
Prednisolone acetate – CAS: 52-21-1
Trenbolone acetate – CAS: 10161-34-9
Hydrocortisone acetate – CAS: 50-03-3
Triamcinolone acetonide – CAS: 76-25-5
Adrenaline – CAS: 51-43-4
Alprazolam – CAS : 28981-97-7
Altrenogest – CAS : 850-52-2
Anastrozole – CAS : 120511-73-1
Androstenedione – CAS : 63-05-8
Anizelam – CAS : 1622-61-3
Estradiol benzoate – CAS: 50-50-0
Biphenyl-4-carbonyl chloride – CAS : 14002-51-8
4-Chlorobutyryl chloride – CAS : 4635-59-0
Clobazam – CAS : 22316-47-8
Codeine monohydrate – CAS : 6059-47-8
Cortivazol – CAS : 1110-40-3
Cyclophosphamide – CAS : 50-18-0
Cyclosporine A – CAS : 59865-13-3
Dapsone – CAS : 80-08-0
Deltandrostenedione – CAS : 1035-69-4
Dexamethasone – CAS : 50-02-2
Dexamethasone 21-mesylate – CAS : 2265-22-7
Dexamethasone sodium m-sulfobenzoate – CAS : 3936-02-5
Dexamethasone Phosphate – CAS : 312-93-6
Dexamethasone Sodium Phosphate – CAS : 2392-39-4
Triamcinolone Diacetate – CAS : 67-78-7
2,4-Dichloronitrobenzene – CAS : 611-06-3
Dicyanoimidazol – CAS : 1122-28-7
4-Dimethylaminopyridine (DMAP) – CAS : 1122-58-3
Doxorubicin – CAS : 23214-92-8
Doxylamine succinate – CAS : 562-10-7
Estetrol – CAS : 15183-37-6
Estradiol hemihydrate – CAS : 35380-71-3
Estradiol Valerate – CAS : 979-32-8
Estrone – CAS : 53-16-7
Etoposide – CAS : 33419-42-0
Firocoxib – CAS : 189954-96-9
5-Fluorouracil – CAS : 51-21-8
Furosemide – CAS : 54-31-9
Ganciclovir – CAS : 82410-32-0
Gemcitabine – CAS : 95058-81-4
Hemisuccinate de medrol – CAS : 2921-57-5
Hemisuccinate prednisolone – CAS : 2920-86-7
Hydrocortisone – CAS : 50-23-7
Ifosfamide – CAS : 3778-73-2
Imidazole – CAS : 288-32-4
Lactose – CAS : 5989-81-1
Leflunomide – CAS : 75706-12-6
Loprazolam – CAS : 61197-73-7
Loprazolam mesylate – CAS : 70111-54-5
Mannitol – CAS : 69-65-8
Methotrexate – CAS : 59-05-2
Methylprednisolone – CAS : 83-43-2
Mitomycine – CAS : 50-07-7
Naproxen sodium – CAS : 26159-34-2
Norethisterone acetate – CAS : 51-98-9
Paclitaxel – CAS : 33069-62-4
Paracetamol – CAS: 103-90-2
p-CPKF (para-cyclopropyl(4-fluorophenyl)methanone) – CAS : 772-31-6
Penicillin G (Benzylpenicillin) – CAS : 61-33-6
Perindopril L-arginine – CAS : 612548-45-5
Perindopril erbumine – CAS : 107133-36-8
Platinum (exposure to cisplatin) – CAS No.: 15663-27-1
Prednisolone – CAS : 50-24-8
Prednisolone 21-methanesulfonate ( – CAS : 35410-28-7
Pristinamycin – CAS: 11006-76-1
Fluticasone propionate – CAS: 80474-14-2
Pseudoephedrine – CAS: 90-82-4
Spiramycin – CAS: 8025-81-8
Tamoxifen – CAS: 10540-29-1
Tamoxifen Citrate – CAS: 748-97-0
Teriflunomide – CAS: 163451-81-8
Testosterone – CAS: 58-22-0
Trenbolone – CAS: 10161-33-8
Triamcinolone – CAS: 124-94-7
Vinblastine – CAS: 143-67-9
Vincristine – CAS: 2068-78-2
Vitamin B12 – CAS: 68-19-9
Comprehensive analytics solutions tailored to your needs
The analytical method used is selected based on the active ingredient being tested. To meet this wide range of needs, Toxilabo has the following equipment, among others:
- HPLC/UV (High Performance Liquid Chromatography with UV Detection)
- HPLC/FLUO (High Performance Liquid Chromatography with Fluorescence Detection)
- LC/MS/MS (Liquid Chromatography Tandem Mass Spectrometry) (photo à droite)
- GC/MS (Gas Chromatography Mass Spectrometry)
Depending on the target active ingredients, air samples can be collected using fiberglass or quartz filters, PTFE membranes, or adsorbent media.
For surface sampling, swab wipes are used to collect residues from the areas of interest.
Do you have a measurement project or a specific need?
Contact us to discuss your project and receive a customized quote.