I. RAW MATERIALS
Each lot of raw materials is quarantined upon arrival and sampled for incoming inspection. The tests performed on these samples range from infrared and ultraviolet chemical analysis to visual and physical tests. Certificates of analysis from the vendors are reviewed against purchase specifications. A written specification exists for each raw material used in the product. When the raw material is accepted, it is released from quarantine for use. If it fails to meet the specification, it is rejected and returned to the vendor or reviewed by the Material Review Board for final disposition.
II. LATEX COMPOUND
Liquid latex is mixed with vulcanizing and processing chemicals to create the condom latex compound. Each batch of compound is assigned a lot number; the raw materials that go into the compound are listed by their own lot numbers to ensure traceability. As each compound lot is finished, it is tested against specified parameters (pH, total solids, chemical and mechanical stability, degree of vulcanization, etc.).
III. DIPPING OF CONDOMS
As the condoms are being produced from the latex compound, various Statistical Process Control (SPC) checks are performed in-process to monitor the quality and to provide feedback to the manufacturing operations. Samples are taken from each product line and are tested by filling with 300 ml of water and examined for both visual and functional defects. Dimensional tests for thickness, length and weight are also conducted on samples from each machine. Data from all the in-process tests are placed on hard copies (forms).
Samples of the latex compound from the dipping tanks are collected daily and checked for pH, total solids and degree of vulcanization, in order to maintain a consistent latex mix on the dipping lines.
Products are formed into lots at the dipping operation to ensure that traceability is maintained throughout the manufacturing processes.
After each lot comes off the production line, the condoms are powdered and dried. Samples are taken from each lot to be tested for strength and dimensions.
IV. ELECTRONIC TESTING
All condoms are electronically tested for pinholes in the manufacturing area. This is accomplished by subjecting them to a high-voltage test that rejects individual condoms that, due to pinholes, allow current to be conducted across the rubber film.
Each electronic testing machine is validated prior to being put into service. In addition the equipment is continuously checked by examining statistically selected samples from each machine and utilizing the water test method throughout the production day.
If a machine is found to be malfunctioning, it is shut down and examined by the engineering staff and is not restarted until the problem is corrected. Product found to have failed testing by established statistical process control procedures is destroyed or is subjected to electronic testing again.
Product that is released from electronic testing is packaged into various configurations. Each of these packaging operations is monitored by a Statistical Process Control Procedure, which involves the selection of product from the packaging line and testing for lubrication quantity, a water test for pinholes, the verification of lot number and expiry dating (which is stamped onto each individual condom pack or consumer pack), and a vacuum test for package integrity.
VI. FINAL TESTING
In addition to the various tests listed above, condoms are also routinely tested for resistance to aging (by oven conditioning at elevated temperatures).
The U.S. Food and Drug Administration performs routine G.M.P. inspections.
Other tasks pertaining to ISO and QSR Regulations are also routinely carried out. These include, but are not necessarily limited to, calibration of equipment, vendor and self-audits, validations and investigation of complaints.