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LABORATORY TESTS

 

The selection of Biochem is distinguished by being customized and tailored to the needs of the customer; it is also diverse and extensive. Biochem has started its activity as a laboratory for microbiological testing of food products and the control of medical devices.

 

 

BIOCOMPATIBILITY

The tests required by ISO 10993 and USP for the evaluation of the safety of the materials used in the biomedical field are meant to highlight the potential and predictable risks associated with the human use.
The tests are chosen according to the type of medical device, its invasiveness, and the duration and type of contact with human tissue.
Biochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals.
Biochem, in addition to execution of the tests, provides a support service in the selection of tests to be performed, the method of operating specific for the device or the material to be examined, also through the drafting of Rational for choice of tests and operating protocols.
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EFFICACY TESTS

Biochem employing a team of talented and competent staff may supply you with a complete service to verify the efficacy of medical devices. Biochem is able to perform screening and/or prolonged tests in order to verify the efficacy of your items versus disease such as allergic asthma, colitis, rhinitis, sinusitis, dermatosis/dermatitis, and other. The efficacy protocols are designed chasing the method of administration, the physical appearance form, the specific requirements and claims that the client appoint to the item. 


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REPROCESSING  FDA

Biochem is able to issue the test  protocols more suitable for You based on the type of device, level of criticality and use, to validate the reprocessing both for microbiological and cleanability as for  absence of disinfection residues.

We have a solid experience of success of several recordings of reprocessing, prices and definitely competitive times with leading international laboratories.


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"> Sales Department to find the best solution for Your needs.

 

 

 

EXTRACTABLES AND LEACHABLES

Biochem offers a comprehensive approach with regards to Extractables/Leachables (E/L) testing and evaluating. Our approach combines a technical and analytical expertise, polymer and rubber knowledge, understanding of regulatory requirements per type of application, all combined in a tailored approach to our customers.

What are extractables and leachables?

Extractables are compounds that can be extracted from a component under extreme conditions, such as the presence of harsh solvents or elevated temperatures.

Leachables are compounds that leach into the drug product formulation from the component as a result of direct contact with the formulation under normal conditions; they are typically a subset of extractables.

These compounds, both organic and inorganic substances, come from plastic components, elastomers, coatings, accelerants, antioxidants, inks, vulcanizing agents, additives, residual solvents or derive from degradation processes. Phthalates are one specific example.

As new delivery devices, disposables, and medical devices are developed, it is certain that FDA will continue to demand information about these components so that the agency can make informed decisions on risk and safety. For this reason the development of E/L testing is of increasing importance.

 

  

TOXICOLOGY

Toxicology studies enable to assess the interactions between substances and biological systems, in order to determine possible adverse effects on health. The toxicology aims to assess the nature and impact of these effects on living organisms, through the examination of biological alterations induced.
Biochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals. Biochem realizes the biocompatibility and toxicology tests required by various Pharmacopoeias, by the UNI EN ISO 10993, chosen according to the type of devices, their invasiveness, and the duration and type of contact with human tissue. The chemical characterization of the component materials of Medical Devices is a preliminary and essential part of the Studies of Biocompatibility, which have increasing importance for compliance with the Animal Welfare.

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MICROBIOLOGICAL TESTS

We perform microbiology tests on different matrices: food, water, cosmetics, medical devices, pharmaceutical preparations, air and work surfaces for all controlled environments (for example in the Hospital Sector; production Galenists, Medical Devices, Aseptic Production, Catering ...).
The Microbiological tests are aimed at qualitative and quantitative research of microorganisms and sterility control.
Biochem also performs:
* tests of antibacterial activity of plastic, metal, and other materials for various purposes
* test of the effecacy of sanitizing agents, disinfectants, sterilants;
* sterilisability test

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CHEMICAL TESTS

We perform chemical tests on different matrices: food, water, rubber and plastics, medical devices, raw materials.
Our laboratory can apply, where existing, official methods (UNI, IRSA, ISO, EPA, FDA, etc.) for the qualitative and quantitative research of substances such as metals, additives, plasticizers, phthalates, residual monomers, VOC, waste processes cleaning or sanitizing disinfection and sterilization. Biochem provides also the tests required for nebulizers by the various International Standards.
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PACKAGING AND MATERIALS IN CONTACT WITH FOOD
PACKING FOR MEDICAL DEVICES

The packaging and materials in contact with food must be produced throughout the supply chain by applying the Good Manufacturing Practices.
Biochem offers services to verify the characteristics of the packaging, for purposes of compliance with the relevant standards for food or protection and preservation of the product in relation to the content material.
The packaging for medical devices must ensure the maintenance of sterility mainly in cases where the product put on the market after sterilization.
Some categories of tests available are:
Chemical characterization of materials, Leak test, Physico-chemical tests, barrier to microorganisms test, dye penetration test, Leaching test, Accelerated aging, Sterility test.
We can develop specific protocols for non-normed test and validate the methods apply.
Main Reference legislation: FDA 21CFR, 2010/11/CE, DM 21/03/1973

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STABILITY TESTS

In pharmaceuticals, food, cosmetics and medical devices, the stability of the active substance must be tested and documented to ensure and prove the preservation of the properties of the product. Biochem is able to design and perform studies on the stability of the product, for example in accordance with ICH guidelines and other Standard. We can carry out tests in various conditions of temperature and relative humidity, to simulate different situations of use and conservation in time. 

From these tests derive information indispensable to evaluate the shelf life of the product and ensure its effectiveness. We can develop specific protocols for not standardized tests and perform validation of the methods to be used.

 


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CONTROLLED ENVIRONMENTS, VALIDATION AND CONTROL OF RATINGS

Biochem offers services for the evaluation of the environment and of the controlled processes, in order to verify and monitor the adequacy of the environments, equipment and procedures, and the compliance with rules.
All of the validation activities are based on the risk analysis approach.
Biochem performs the measurement of particulate contamination and counting of microorganisms in the air of all Controlled Environments, the White House, the extractor fans or areas that require specific controls air to assess the degree of cleanliness, in accordance with ISO 14644 and ISO 14698.
Biochem also offers: operating procedures of the personnel and procedures for cleaning sanitization (rooms, equipment; evaluation of the treatment and conditioning systems efficacy, definition of environmental parameters reference, validation of the process of sanitizing, pasteurisation, sterilization, inactivation of viruses; particles and microbial controls; training courses for the staff).

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WATER ANALYSIS

The analysis of water is essential for the protection of health and of the environment. The analysis consists in finding microorganisms dangerous to humans (eg Legionella) in addition to any chemicals, as required by the rules in the reference standards. We can agree on preliminary inspections to identify where necessary, a sampling plan.

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