A medical device is a healthcare product. The term refers to any instrument (device, apparatus or other element) used alone or in combination, including the software necessary for its operation. Such devices are intended for human use to :
– diagnose, prevent, control, treat or attenuate a disease, injury or disability,
– study, replace or modify anatomical structures or physiological processes,
– control conception.
Its main effects in or on the human body are not obtained by pharmacological, immunological or metabolic means, but its functions may be assisted by such means. It performs its medical action by mechanical means.
Many different products meet this definition. For example: dressings, prostheses, scanners, bandages, external defibrillators, etc.
Pharmaceutical products means all articles whose management is handled by pharmacists. They include a wide range of products intended for improvement of health, by enabling either the administration of a treatment, the application of a diagnosis or the preparation of the pharmacists’ own medicinal products.
There is a basic classification of pharmaceutical products which is used in most cases in pharmaceutical product storage places (consignment stores, wholesale distributor stores, pharmaceutical warehouses, etc.). Pharmaceutical products are divided into five main families:
- medicinal products,
- consumable items (dressings, bandages, etc.)
- medical equipment,
- laboratory equipment,
- miscellaneous equipment.
Veterinary products are important tools in the prevention and control of animal diseases. The definition of this term may vary from one country to another. The definition used by the OIE (the World Organization for Animal Health) includes vaccines, medicinal products for veterinary use, such as antimicrobial agents, and diagnostic kits.
To guarantee simultaneously effective and lasting control of animal diseases while at the same time reducing risks to humans and animals to a minimum, governments must include suitable provisions in their veterinary legislation to regulate the authorization for marketing, manufacturing, distribution and use of veterinary products.
PHARMACEUTICAL & VETERINARY PRODUCTS
According to Article L5111-1 of the French Public Health Code, “a medicinal product is any substance or composition presented as possessing curative or preventive properties with respect to human or animal diseases, together with any product which can be administered to humans or animals with the aim of making a medical diagnosis or restoring, correcting or modifying their organic functions.”
The various forms taken by medicinal products are:
- dry oral forms (tablets and capsules)
- injectable medicinal products (ampoules)
- vaccines and insulins
- medicinal products for external use (dermatological and gynecological preparations, including local contraceptives)
- ophthalmic medicinal products for external use
Chemistry is an experimental natural science which studies the composition of matter and its transformations. It thus investigates the elements which constitute matter (atoms, ions, etc.), their properties and the chemical links which may form between them.
Chemistry also studies the transformations of matter which involve changes to the external electronic layers: chemical reactions (oxidation/reduction, acid-base reactions, etc.), ionization, and so on.
Chemical formulae serve to represent molecules in a simple way and are used in chemical equations.
There are several disciplines which possess common points while working on different objects of study:
- organic chemistry (elements containing carbon),
- analytical chemistry (identification of chemical substances),
- biochemistry (reactions which involve biological media or objects (cells, proteins, etc.)),
- astrochemistry (chemical elements within the universe).
An equipment supplier is a manufacturer or seller of equipment, i.e. of electronic or electronic products used in the outfitting of premises.
A clean room as defined by standard ISO 14644-1 (also called a white room) is a room or a series of rooms in which the particle concentration is controlled in order to minimize the introduction, generation and retention of particles inside it, generally for a specific industrial or scientific research purpose. Parameters such as the temperature, the humidity and the relative pressure are also maintained at a precise level (definition as per standard ISO 14644-1).
Clean rooms are used in fields which are sensitive to environmental contamination: manufacturing of semi-conductor devices, biotechnologies and other fields of biology, preparation of sterile pharmaceutical products, construction of optics or micro-mechanisms, etc. Such rooms are also used in medical research for the production of radioelements, for example.
The OECD (Organization for Economic Cooperation and Development) defines biotechnology as “the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services”.
Medtech is a contraction of “medical” and “technology”. The WHO (World Health Organization) defines the concept as “the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”.
Medtech encompasses all technologies intended for the healthcare environment and can refer as much to a website for making online appointments as to an artificial organ.
According to the Ministry of Health and Solidarity, a cosmetic product is a “substance or mixture intended to be brought into contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and the external genital organs) or with the teeth and the buccal mucosa, solely or principally for the purpose of cleaning them, scenting them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odors”. The definition of cosmetic products is common to all member states of the European Union (Article 2 of the Cosmetics Regulation). It is transcribed in France into the Public Health Code (Article L.5131-1).
- creams, emulsions, lotions, gels and oils for the skin,
- face masks,
- toilet soaps, deodorant soaps,
- perfumes, toilet waters and eau de Cologne,
- bath and shower preparations (salts, foams, oils, gels),
- hair-waving products,
- products for dental and oral hygiene.
An antiseptic is a product which destroys bacteria, fungi or viruses or prevents their multiplication and thus serves to treat, combat or prevent infections. Antisepsis consists in neutralizing the microorganisms present on an area of skin or mucosa, whether healthy or injured. Its effect is temporary and its use is more curative than preventive.
The effectiveness of antiseptics depends on the composition of the microorganisms or their form (vegetative or spore), natural or acquired resistances, the environment, etc. Antisepsis is therefore carried out in accordance with the recommendations associated with the medical act. Combined use of several antiseptics must always be avoided. It is liable to cancel out their effects or, in some cases, may lead to the formation of irritant products.
A disinfectant is a substance capable of destroying or preventing the development of germs on inert media (non-living media such as floors, instruments, etc.). It is used to eliminate or kill the microorganisms in a place or on a surface. This also serves to inactivate pathogenic viruses in contaminated media, matter or materials by altering their structure or by inhibiting their metabolism or some of their vital functions.
Disinfection is a deliberate momentary operation to eliminate certain germs (otherwise we speak of sterilization).
Routine tests on medical devices
- NF EN ISO 11737-1: Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products.
- NF EN ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process.
- NF EN ISO 10993-7: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.
- NF ISO 15798: Particle counting on ophthalmic implants.
- NF EN 45502: Particle counting by light blocking on pacemakers or implantable medical devices.
- NF ISO 19227: Surgical implants – Cleanliness of orthopedic implants – General requirements.
- NF EN 14683+AC: Medical face masks – Requirements and test methods
- AFNOR SPEC S76-001: Barrier masks – Guide to minimum requirements, methods of testing, making and use.
- NF EN ISO 14729: Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses.
- NF EN ISO 9377-2: Water quality – Determination of hydrocarbon oil index – Part 2: Method using solvent extraction and gas chromatography. USP <161>: Medical devices: bacterial endotoxin and pyrogen tests.
- Tests of sterility outside the context of validation of the sterilization process: Aerobic and anaerobic bacteria, yeasts, moulds (PE 2.6.1).
- Bacterial endotoxin tests: Determination of bacterial endotoxin concentration by the limulus amoebocyte lystate (LAL) test (PE 2.6.14).
QUALIFICATION OF PACKAGING: ACCELERATED AGING, MICROBIAL BARRIER TESTING BY AEROSOL AND BY IMMERSION, TRANSPORT SIMULATION
- NF EN ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- NF EN ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes.
- ASTM F 1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- ASTM F1886 / F1886M – 09: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
- ASTM D3078: Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- NF EN ISO 868-5: Packaging materials and systems for medical devices having to be terminally sterilized – Part 5: Heat-sealable bags and sleeves comprising a porous material face and a plastic film face for terminally sterilized medical devices.
- Pharmaceutical package integrity – Technical Report no. 27
- ASTM F1608-16 “Standard test method for microbial ranking of porous packaging materials (exposure chamber method)”
biocomptability & TOXICOLOGy
tests & EVALUATIONS
- ISO 10993-1: Drafting of the biological evaluation plan (risk management process, general classification of the product, evaluation of existing data, etc.) and the biological evaluation report.
- ISO 10993-2: Follow-up of recommendations on animal ethics.
- ISO 10993-3: Evaluation of genotoxicity, carcinogenicity and reproductive and developmental toxicity.
- ISO 10993-4: Evaluation of interactions with blood.
- ISO 10993-5: Evaluation of cytotoxicity.
- ISO 10993-6: Evaluation of local effects after implantation.
- ISO 10993-9: Evaluation of potential degradation.
- ISO 10993-10: Cutaneous and intradermal tolerance.
- ISO 10993-10: Sensitization.
- ISO 10993-11: Systemic toxicity.
- ISO 10993-11: Pyrogens.
- ISO 10993-12: Sample preparation.
- ISO 10993-13: Polymer degradation.
- ISO 10993-14: Ceramic degradation.
- ISO 10993-15: Degradation of metallic medical devices.
- ISO 10993-17: Drafting of toxicological evaluation reports.
- ISO 10993-18: Chemical characterization of medical devices.
- ISO 10993-22: Biological evaluation of medical devices – Part 22: Guidelines on nanomaterials.
ISO 10993-23: Biological evaluation of medical devices – Part 23: Irritation tests.
VALIDATION & QUALIFICATION
Qualification & testing of controled contamination areas
- NF EN 17141 (ISO 14698 if requested): Sampling and control of biocontamination of surfaces, personnel and air. (ISO 14698 if requested)
- USP <1116>: Microbiological control and monitoring of aseptic processing environments.
- NF EN ISO 14644-1: Particulate tests.
- NF EN ISO 14644-3: Physical tests: recovery time tests, airflow schemes, renewal rates, T° and RH%, speeds, filter integrity checks.
- NF EN 14175-3, NF EN 14175-4, NF X15-211, NF EN 12469: Fume cupboards.
- Biological Safety Cabinet (BSC) / Flow hood
Qualification of compressed gas networks
- NF EN 17141 (ISO 14698-1 if necessary): Microbiological tests.
- ISO 8573-4: Particulate tests.
- NF ISO 8573-1, NF ISO 8573-2, NF ISO 8573-3: Physico-chemical tests.
- On-site checking of critical measurement systems.
- Thermal mapping.
- FDX 15140: Thermostatic and climatic chambers.
- XP CEN ISO/TS 15883-5, NF EN 15883-1, NF EN 15883-2, AAMI TIR12: Washers/disinfectors.
- Validation master plan.
- DQ/IQ/OQ/PQ protocol and report.
- Risk analysis.
- Project management assistance.
Identification of microorganisms basteria, yeasts, moulds
- Genus characterization.
- Species identification.
- Genotypic identification.
TESTING ON PHARMACEUTICAL PROCESS WATERS
- Monograph 04/2018:0008 – Purified water: Physico-chemical, microbiological and endotoxin analyses.
- Monograph 04/2017:0169 – Water for injections: Physico-chemical, microbiological and endotoxin analyses.
- Monograph 01/2009:1927 – Highly purified water: Physico-chemical, microbiological and endotoxin analyses.
- USP <1231>: Water for pharmaceutical purposes.
- Ph. Eur. 2.2.38.: Conductivity.
- USP <645>: Water conductivity
tESTING ON PHARMACEUTICAL & VETERINARY PRODUCTS
- Ph. Eur. 2.6.1.: Sterility.
- USP <71>: Sterility tests.
- Ph. Eur. 2.6.12.: Microbiological examination of non-sterile products – Microbial enumeration tests.
- USP <61>: Microbial enumeration tests.
- Ph. Eur. 2.6.13.: Microbiological examination of non-sterile products – Tests for specified microorganisms.
- USP <62>: Tests for specified microorganisms.
- Ph. Eur. 2.6.27.: Microbiological examination of cell-based preparations.
- Ph. Eur. 2.6.31.: Microbiological examination of herbal medicinal products for oral use.
- Ph. Eur. 2.6.36. & 2.6.38.: Microbiological examination of live biotherapeutic products.
- Ph. Eur. 5.1.4.: Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use.
- Ph. Eur. 5.1.8.: Microbiological quality of herbal medicinal products for oral use.
- Ph. Eur. 2.6.14.: Bacterial endotoxins, quantification by qualitative gel-clot method and quantitative kinetic colorimetry method.
- USP <85>: Bacterial endotoxins test.
- Ph. Eur. 2.7.2.: Microbiological assay of antibiotics.
- USP <81>: Antibiotics microbial assays.
- Ph. Eur. 5.1.1.: Methods of preparation of sterile products.
- Ph. Eur. 5.1.2.: Biological indicators of sterilization; supply and quantification after sterilization cycle.
- USP <1229.5>: Biological indicators for sterilization.
- USP <55> Biological indicators: resistance performance tests
- Ph. Eur. 5.1.3.: Efficacy of antimicrobial preservation.
- USP <51>: Antimicrobial effectiveness testing.
- Fertility of culture media (agar media and liquid media).
- Validation of microbial recovery from pharmacopeial articles <1227>.
- Ph. Eur. 2.2.44.: Total organic carbon in water for pharmaceutical use.
- USP <643>: Total Organic Carbon.
- Ph. Eur. 2.9.19.: Particulate contamination: sub-visible particles.
- Ph. Eur. 2.9.20.: Particulate contamination: visible particles.
- USP <788>: Particulate matter in injections.
- USP <789>: Particulate matter in ophthalmic solutions.
- NF EN ISO 8871-3: Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 3: Determination of released-particle count.
TESTING OF ANTISEPTICS AND DISINFECTANTS
- Basic standards (NF EN 1040, NF EN 1275, NF EN 14347, NF EN 14885).
- Application standards (phase 2, step 1: NF EN 1276, NF EN 1650, NF EN 1656, NF EN 1657, NF EN 13624, NF EN 13704, NF EN 13727 , NF EN 14204, NF EN 14348, NF EN 17126):
> Tests for bactericidal activity
> Tests for fungicidal activity
> Tests for sporicidal activity
- Application standards (phase 2, step 2: NF EN 1499, NF EN 1500, NF EN 12791, NF EN 13697, NF EN 14349, NF EN 14562, NF EN 14563, NF EN 16437, NF EN 16438, NF EN 16615):
> Tests for bactericidal activity
> Tests for fungicidal activity
> Tests for sporicidal activity
> Tests for myobactericidal activity
- USP <1072>: Disinfectants and antiseptics.
- Ph. Eur. 5.1.11.: Determination of bactericidal, fungicidal or yeasticidal activity of antiseptic medicinal products.
ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces.
NF EN ISO 11138-1/2/3/4/5/: Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO / NP 11138-6: 2009-02-13) – draft standard.
- Manufacturing of germ carriers on any support and biological indicators:
> Stainless steel coupon
> Standard pin
NF ISO 11138-1: Determination of D Value.
CUSTOMIZED STEAM AUTOCLAVE STERILIZATION
- Equipment and cycles validated in compliance with cGMP.
- Supplies of calibrated ATCC strains.
- Supply of ATCC strains for qualification of the VITEK 2 automated system.
THE ICARE GROUP GUIDES YOU IN EVERY STAGE OF THE HEALTHCARE PRODUCT LIFECYCLE
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- Laboratory testing
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- Methods & Development
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Your projects are at the heart of our mission. Healthcare products follow a life cycle, which we fully master to guide you at every stage and in all your steps. From the concept to the monitoring of your production, our teams of experts provide you with appropriate solutions.