ABSTRACT

From the earliest recorded history of man, samples of materials and substances have always been taken to represent the bulk quantity in trading transactions and direct sales. Special sampling considerations have developed from simple procedures such as keeping food samples cool to reduce the rate of spoilage. Microorganisms such as yeasts, bacteria, and molds need to be controlled, inactivated, or removed to meet today's regulatory requirements for food and drug products. The primary goal for any sampling system, aseptic or not, is to obtain a representative sample that is properly handled so that the desired analytical test can be conducted. Two general types of sampling methods are normally used in bio-systems and drug processes: indirect—the sample is removed from the bulk material and placed into an external container for transport to the analytical testing area; direct—the analytical test is conducted directly in the bulk material without a sample being removed. This is also called in situ sampling.