Service

Micro-Serve Laboratory

Einsteinstraat 35 , 3902 HN Veenendaal
Netherlands

Telephone +31 (0)318 501633
Fax +31 (0)318 501640
info@micro-serve.nl

This company is co-exhibitor of
Task Force Health Care

Trade fair hall

  • Hall 15 / F55
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 15): stand F55

Fairground map

MEDICA 2016 fairground map: Hall 15

Our range of products

Our products

Product category: Bacteriology

Validation studies according to ISO 11137-2

Micro-Serve laboratory provides a coordination service of the initial bioburden and sterilization validations along with a full validation report.
The main advantage of this very thorough and cost-effective approach is that it covers all areas of the ISO-11137-2 requirements.
Micro-Serve laboratory has many experience providing validations for unique or complex medical devices, or medical devices that cannot handle large doses of radiation.

A radiation validation determines the appropiate radiation sterilization dose for a medical device that requires a sterile label claim.
Usually the sterilization dose must represent a sterility assurance level (SAL) of 10-6, which means a one in a million probability of a non-sterile product.
The validation incorporates a bioburden recovery efficiency test, bioburden testing, a sub-lethal radiation dose (verification dose) and sterility testing.

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Product category: Bacteriology

Bioburden testing

Bioburden is a common name for the number of colony forming units on a product.

For Medical Devices the Bioburden is commonly determined after production and in the final packaging, but before sterilization.
The level of Bioburden is an important parameter for the sterilisation process of the devices.
Bioburden is an overall name for the total contaminaton of the product with (an)aerobic bacteria, Yeasts and Moulds.

Bioburden and microbiological validation
When a product is validated according to ISO 11137-2 method 1, there is a direct relation between the level of Bioburden and the required minimum dose of Gamma Radiation in order to claim a Sterility Assurance Level of 10E-6.

Using ISO 11137 method VDmax25 the Bioburden limit shall not exceed 1000 cfu/unit. Next to VDmax25 (which substantiates 25 kGy as a routine sterilisation dose) also other doses can be validated. Depending on the product Bioburden this range can be from 15 kGy to 35 kGy.

Bioburden and monitoring
After a succesful validation it is required to monitor the Bioburden after production of the next batches. Part 1 of ISO 11137 gives information concerning “Maintaining process effectiveness”. We can inform you about the most effective way of monitoring the Bioburden on your product.

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Product category: Bacteriology

Sterility testing according ISO 111737-2

As manufacturers of medical devices are requested to demonstrate the sterility of their devices, sterility testing is an essential part of every sterilization validation as well for routine quality control of medical devices.

As sterility is a theoritical value, and so for medical devices to claim sterility, various tests
are required to ensure that the sterilization process used is effective and to prove the devices’ sterility assurance level (SAL).

Sterility testing methods
The sterility test will be performed with direct inoculation using TSB medium at incubation conditions 14 days at 28 °c – 32 °c. In these period we actively monitor the samples for evidence of microbial contamination.
To detect aerobic organisms, Soybean Casein Digest medium (SCD), also known as Trypticase Soy Broth (TSB) is usual used.
The number of positive results will be observed for the sterility determination.
In order to validate the sterility test, after the incubation period a growt promotion check will be performed to exclude false negative results on a regular base.

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Product category: Bacteriology

Bacterial endotoxins Test

Bacterial endotoxins test is an assay to detect and quantitate bacterial endotoxins which causes heat or feaver within the body.
In the medical device industry it are the endoxins, a component of the cell wall of gram negative bacteria, that usually causes the pyrogenic reaction.

Bacterial endotoxins are very difficult to remove, heat stable and toxicity is not dependant on the presence of the bacterial cell. They often remain present, even after the cells die and are considered the by-product of lysis for certain types of microorganisms.

It is thought that water supply is the most likely source of gram-negative bacteria of which the outer cell wands contain endotoxins. To ensure that the process does not contribute endotoxins to the final product routine monitoring of water systems and incoming materials can help.

A bacterial endotoxins test is performed as a part of lot release testing for medical  devices to ensure its endotoxine free. The test need to be performed for medical devices with direct or indirect contact to the lymphatic system, cardiovascular system or cerebrospinal fluid.

Micro-Serve provides bacterial endotoxins tests for several areas of the manufacturing and production including:

•Final poduct release testing
•Raw materials testing
•Bulk lot release testing

The bacterial endotoxins test is also know as the Limulus Amebocyte Lysate (LAL) test.

Micro-Serve has many experience in bacterial endotoxins testing for clients in the medical device industry. With a proven effective and compliant process We provide the highest quality testing and fast turnaround time.

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Product category: Bacteriology

Accelerated aging

Accelerated Aging testing is a fast procedure for establishing the expiry date or shelf life of a product.

Data obtained from the study is based on conditions that simulate the effects of aging on the materials. A product can be released to market based after successful Accelerated Aging test results that simulates the period claimed for product expiration date (1 year, 2 years, etc).

Accelerated Aging data is accepted by regulatory bodies as a provisional estimate of the shelf life, but is only completely accepted until those tests can be supplemented with “real time” aged samples.

Accelerated Aging calculation is based on Arrhenius’ equation which simply states that a 10 °C increase in temperature doubles the rate of chemical reaction.

Four variables are used in calculating the accelerated aging test duration.

•Accelerated Test Temperature (°C)
•Ambient Temperature (°C)
•Q10 (Reaction Rate Factor)
•Desired Real-time equivalent (Days)
•Test Temperature is typically between 50 to 60C, most common 55°C
•Ambient storage temperature is typically between 22°C to 25°C. 22°C results in the shortest test duration.
•Conservative / common Q10 is 2 for medical devices.

The expiry date of a medical product is commonly based on its manufacture date. Therefore, some add an extra month to the aging study to allow for sterilization, etc. For example, a 12 month shelf life is simulated based on 13 months.

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About us

Company details

Micro-Serve microbiological laboratory has many years of experience in the field of (gamma-)sterilization and microbiological testing of Medical Devices. We offer a high level of knowledge of the applicable standards like ISO 11137, ISO 11737 and TIR 33.
Our deep knowledge and process flexibility makes us your right partner concerning a validation protocol, perform laboratory tests and reporting all results.
The business concept of Micro-Serve laboratory is to supply a total range of microbiological tests, validations and related services.
Our services are specifically for the CE-mark sterile medical devices, designed to specific client requirements and meet the respective ISO standards.

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