Test laboratory cleanliness
Based on our years of experience, we see ourselves as experts in cleanliness and cleaning of medical devices.
By cleanliness we mean the absence of chemical impurities, microorganisms or endotoxins, after the manufacturing process or after cleaning, disinfection and sterilisation of medical devices.
To do so, we provide our customers with the following services from our company or through qualified cooperation partners:
- Examination of chemical residues after the manufacturing or cleaning process
- Bioburden, endotoxin and cytotoxicity testing associated with cleaning validations
Cleaning validation
Sterile medical devices are usually manufactured and packaged under cleanroom conditions. This limits the contamination of the products with microorganisms or endotoxins released by them.
While sterilisation-resistant endotoxins pose an immediate risk to patients, it is necessary to limit the bacterial count in order not to endanger the success of the subsequent sterilisation.
In addition to production under cleanroom conditions, disinfectant cleaning of the medical devices prior to final packaging is crucial. By integrating a cleaning step, the cleanroom production conditions can often be limited to the subsequent packaging processes.
For this purpose, the cleaning process is examined for its suitability for removing specific production residues. The tests we offer include bioburden determinations, endotoxin tests and cytotoxicity tests.
Microbial count determination / bioburden determination on medical devices and pharmaceuticals according to ISO 11737 or Ph. Eur. 2.6.12
The term microbial count or bioburden refers to the type and number of detectable bacteria and fungi that are present on a product prior to sterilisation.
To detect these, a sample is either dissolved in a suitable test solution or the microorganisms are rinsed off and then cultivated. The result is traditionally a number of grown colonies, which is why the result is expressed in colony-forming units (CFU).
In order to correctly determine the type and number of micro-organisms, a comprehensive validation of the determination method is necessary.
Test for bacterial endotoxins according to Ph. Eur. 2.6.14 or 2.6.32, according to ISO 11737-3 and USP Chapters 85 and 161
BBF Sterilisationsservice GmbH has many years of experience and proven competence in the detection of endotoxins and carries out these tests for you in accordance with the applicable standards and regulations.
Pyrogens are substances which, even in small concentrations, trigger fever reactions, a drop in blood pressure and life-threatening shock in both humans and animals. The most important group of pyrogens are lipopolysaccharides from the cell membrane of gram-negative bacteria, usually referred to as endotoxins, which are released when the microorganisms die or the cell membrane disintegrates. They are very thermally stable and cannot be removed or inactivated by conventional sterilisation processes.
For the endotoxin determination the units are indicated in endotoxin units per ml (EU/ml). The determined endotoxin content is compared with the applicable limit value or the one specified by the customer.
We offer the following endotoxin determination methods as limit or quantitative tests:
Since the majority of pyrogens are due to endotoxins, especially lipopolysaccharides (cell wall components of gram-negative bacteria), the Limulus amebocyte lysate test (=LAL test) was developed for their detection. For this test components from the blood of the horseshoe crab are used which coagulate on contact with lipopolysaccharides. The test is carried out according to the Ph. Eur. 2.6.14 and USP chapter 85 as well as in the field of medical devices according to ANSI AAMI ST 72 and USP chapter 161.
We mainly conduct the test as a limit value test. This means our customer defines his limit value, e.g. 20 EU per product unit and we test dilutions below this limit value to ensure the acceptance criteria. The endotoxin content can optionally be determined quantitatively in our laboratory.
In order to produce lysate, the animals must undergo a risky blood sampling procedure. In addition, the lysate reacts not only to lipopolysaccharides but also to beta-glucans. These are polysaccharides found in the cell walls of plants, bacteria and fungi, such as cellulose or chitin.
That is why biotechnologically produced equivalents have been preferred in recent years. See recombinant factor C test in this context.
We offer testing for the detection of bacterial endotoxins in two variants of the recombinant factor C test according to Ph. Eur. 2.6.32: the typical recombinant factor C test and the test based on ELISA (enzyme-linked immunosorbent assay) for Elimination of disruptive factors in advance. Both test systems offer the possibility of quantitatively determining the amount of endotoxin and are equivalent to the classic LAL test according to Ph. Eur. 2.6.14.
In the case of the Recombinant Factor C test, the decisive enzyme, the so-called Factor C, which can usually be found in the blood of horseshoe crabs, is biotechnologically produced. The pure enzyme eliminates false-positive results, which may result from beta-glucans, for example.
In-vitro cytotoxicity test according to 10993-5
The in-vitro test for cytotoxicity is the most common biosafety test according to ISO 10993.
Our laboratory has an ISO 17025 accreditation for this test and has many years of experience with this cell culture-based test system, which is often used not only for end product testing, but also for monitoring cleaning processes, for example, or for the selection and inspection of incoming materials and raw materials or intermediate products.
In this test, an extract of the product to be tested is created. For this purpose, we have developed suitable extraction options for a wide variety of medical products.
The extract is brought into contact with the test cells. The viability of the cells is then determined by visual detection of a vital dye. A reduction in viability of more than 30% indicates a cytotoxic reaction.
Your contact persons
Should you have any questions about our services, please do not hesitate to contact us.
