Sterile sampling containers in various sizes from CleanControlling.
In the manufacture of medical devices, high standards of product cleanliness must be maintained and guaranteed. Medical devices must be free of residues or contamination of any kind, as far as technically possible, to ensure the safety of the user or patient. To ensure this safety and to provide the necessary evidence of product cleanliness, samples must be taken and analyzed regularly in production and packaging.
During sampling, a random sample is taken from a material to be tested according to a defined procedure, and this sample is stored in a sampling container until it is analyzed. The sampling container protects the sample from contamination and enables safe transport to the laboratory. The sampling containers are made of high-quality PP, which complies with USP Class VI, and have very good chemical, thermal and mechanical stability. The lids of the containers are made of PE. The sampling containers, which can be ordered in 15 ml and 50 ml sizes, are transparent and have a printed scale in 1mm and 5 ml increments, respectively. This makes the contents and fill level easy to see, even without opening the container.
In addition to the removal of production residues, microbiological cleanliness plays a decisive role in the safety of medical devices, especially if the medical devices enter a sterilization process immediately after cleaning. Here, a defined biological load level must not be exceeded in order not to jeopardize the sterilization success.
Sterile sampling containers for the safe handling of samples
For the reasons mentioned above, all sampling containers that can be ordered from CleanControlling are radiation sterilized and comply with class SAL 10-6. Radiation sterilized means that each container has been sterilized during production by irradiation with ionizing radiation to kill all viable microorganisms on the surface. The SAL 10-6 label stands for "Sterility Assurance Level" and indicates how likely it is that the product is not sterile. For example, an SAL of 10-6 means that the probability of a microorganism remaining on the product is less than 1: 1 million. In other words, the product has a sterility of 99.9999%.
The endotoxin level of the sampling containers is <0.5 EU/ml, which means less than 0.5 endotoxin units per milliliter. Furthermore, the containers are free of DNase and RNase and thus also meet the strict requirements in the fields of molecular biology, genomics as well as forensics.
The sampling containers can be ordered in packaging units of 10 pieces each. For orders within Germany we charge 15 Euro shipping costs; the costs for shipping to Europe and North America are listed on an overview page in our store. If you have any questions about shipping costs to other destinations or delivery times outside Europe, we will be happy to answer them on request.
Also, if you have any questions about our other offerings in the areas of assembly cleanliness, particle monitoring or medical, or if you would like additional information about our sampling containers, we would be happy to hear from you. Simply use our contact form, send us an e-mail to firstname.lastname@example.org or fax your inquiry to +49 74 65-929678-10. You are also welcome to contact us by phone during business hours; you can reach our team at +49 7465 929 678-0.