Quality control 1
All our suppliers must have a certified quality control System and CPR audits them at regular intervals. The supplied raw materials must comply with CPR’s specifications. Our goods receipt inspection of latex comprises the following parameters: viscosity, mechanical stability, coagulum content, total solids contact and temperature. Some of these tests are frequent during the compounding and maturing process. The test data are stored for a period equal to the lifetime of the condoms.
Latex & compounding
Several chemicals are milled to archive specified particle sizes. Afterwards, these chemicals are mixed with latex, water, and soap for a period of 24 hours. When the mixing is finished, the compound is filled into special tanks for maturing. The maturing is carried out at a specified temperature for 10 days. After that time, the compound is ready for dipping.
Quality control 2
During the dipping process, all process data are documented and stored: Data such as temperature of the machine, speed, room temperature (once every hour), viscosity and maturing degree of the compound (every second day). We store approx. 26 different process parameters per hour for 1 dip-line only.
The process of condom manufacturing is called dipping, because it is performed by glass formers mounted on an endless chain dipping into liquid latex. The first dip being finished, the latex is dried, and the glass former enters a second dip tank. Afterwards, the latex film dries again, and the bead is made by means of a brush system. The glass former then moves into the vulcanization tunnel where it is heated to 115° C. When the glass former leaves the vulcanization tunnel, the latex film is tightly on the form. After this, the glass former came through a soaking tank, in which the latex film is loosened so that the condom can be stripped-off by means of brushes afterwards. The glass former is cleaned before the next production round is starting.
Quality control 3
At that stage of the production process, we can test the quality of the condom for the first time before they are conveyed to the powdering process. We check the weight of the condoms and continue with a visual inspection.
Washing, spin drying & tumble drying
To avoid that the condoms stick together, they are powdered in industrial washing machines. After the powdering, the condoms are spin-dried and tumble-dried at 110° C to remove all the water and humidity as well as to continue the vulcanization.
Quality control 4
After the condoms have been powdered, we continue with a detailed test carried out once per sub batch. Out of a quantity of 10.800 condoms, we check 100 pcs. for pinholes, 20 pcs. for visual defects by blowing them up, 7 pcs. for burst volume and burst pressure. Furthermore, we perform test regarding length, wall thickness, force at break, and tensile strength. This “In-Process Test” gives us an overview regarding the quality of our condoms shortly after the production process and enables us to take quick corrective measures in case that any of the stipulated parameters should not be fulfilled. Having passed the tests, the condoms are ready to enter the next production step, in which each of the condoms is now tested for pinholes.
Testing & foiling
Each of the condoms is tested for small holes at the voltage of about 2.000 V. For that purpose, the condom is pulled over a metal mandrel moving in such a way as to get into contact with a conductive rubber. An intact condom is an isolator; in this case, no electrical current will be measured. Otherwise, if there is a hole in the condom, the electronics of the testing machine will measure an electronic current, and the condom will be rejected. The good condoms are conveyed to a foiling machine. During the foiling process, the batch number and the expiry date are printed onto the foil. The lubricant is applied on the condom while pincers pull the condom between the upper and lower foil before the foils are sealed together.
Quality control 5
Having tested and foiled each condom, we check the condoms for pinholes again on special laboratory equipment to make sure that all the pinholes were found in the previous manufacturing process. 20 samples are drawn from each of the machines once per hour and checked for pinholes, integrity of the foil, correct batch-no., correct expiry date and the correct amount of lubricant applied to the condom.
The foiled condoms are put into the consumer boxes together with a leaflet. The batch number and the expiry date are printed onto the boxes. Depending on the batch size, a defined number of samples are drawn to check the quality of the batch in question. In most cases, the condoms are tested according to ISO 4074 or according to customer/country standards. Each of the condom batches has to pass these tests before it is released for shipment to our customers.
Quality control 6
After the foiled condoms are packed into consumer boxes, we check again the content of the boxes and if the batch-no. and the expiry date are printed correctly. We also carry out a visual inspection regarding the outward appearance of the boxes. The manufacturing process is now finished, and each condom batch we manufactured has to pass the test for the final release carried out by our laboratory personnel. The condoms will only then be released for shipment to the consumer.
Final product release
Every condom belongs to a batch that has been assigned a batch number prior to the start of the production process. Depending on the size of the batch, a defined number of samples have to be drawn to check the quality of the beach of condoms. The number of samples to be drawn is defined by all international quality standard. The condoms are mostly tested according to ISO 4074 or according to consumer/county specific standards. Each condom batch has to pass these tests before it is released for shipment to our customers.
Quality control 7
Now all tests described below are carried out for the final batch test. Furthermore, we retrieve a specific number of retaining samples from each batch and store them in our warehouse. 1-2 % of all condoms we manufacture are used for quality testing purposes and thus destroyed during process. A typical condom batch size out of a continuous production consists of 150.001 to 500.000 condoms. Out of this quantity the following samples are taken for testing at CPR according to the standards: 315 for pin hole test, 315 for burst volume and pressure test, 13 for dimension test as wall thickness, length and width, 32 for integrity test, 315 for visual inspection of the condoms, 13 for consumer packing & labelling test.
Based on customer requirements we ship our products by sea freight, airfreight or truck to the place of destination. For every batch a quality certificate is issued by the QC and attached to the shipping documents.