ABSTRACT
Contract laboratories, like contract sterilizers, are an extension of the manufacturer’s operation. Contract sterilizers provide a manufacturing process, namely sterilization, whereas contract laboratories function as an extension of the manufacturer’s quality assurance program. By building a relationship with a contract laboratory at an early stage, medical device manufacturers gain the advantage of having the contract lab understand the qualification studies that support the routine manufacturing and testing of product. Contract laboratories can provide services that address all of the requirements when a manufacturer chooses not to perform them internally. Most contract laboratories stress client confidentiality and are often willing to sign nondisclosure agreements, if necessary. In addition to performing tests in programs designed to qualify materials and production processes, contract laboratories must also qualify many of the tests performed with medical device manufacturers’ product. The US Pharmacopeia describes the Bacteriostasis/Fungistasis test that must be performed to validate the sterility test procedure being employed when a product is tested.
