System, Open
A system which fails to meet one or more of the criteria which define a closed system. (TR28)
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Sterility Test
Test performed to determine if viable microorganisms are present. (TR28) (TR62)
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System, Closed
A “closed” system is sterilized-in-place or sterilized while closed prior to using a validated procedure, is pressure and/or vacuum tight to some pre-defined leak rate maintained through the length of the campaign, can be utilized for its intended purpose without breach to the integrity of the system, can be adapted for fluid transfers in and/or out while maintaining asepsis, is connectable to other closed systems while maintaining integrity of all closed systems (e.g., Rapid Transfer Port, steamed connection, etc.), is safe guarded from any loss of integrity by scheduled preventative maintenance and utilizes sterilizing filters for sterilization of process streams which are integrity tested and traceable to each product lot. (TR28)
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Process Simulation (without microbiological growth media)
Method of evaluating an aseptic process employing methods which closely approximate those used for sterile materials using an appropriate material. (TR28)
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Process Simulation (with microbiological growth media)
Method of evaluating an aseptic process using a microbial growth medium employing methods which closely approximate those used for sterile materials. (TR28)
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Microbial Count Determination
A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)
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Growth Promotion Test
Test performed to demonstrate that media will support microbial growth. (TR22) (TR28)
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Environmental Monitoring Program
Defined documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas, and includes a corrective action plan when action levels are exceeded. It includes assessment of environmental air, surfaces and personnel. (TR22) (TR28) (TR62)
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Closed System
An isolated system that has no interaction with its external environment, preventing contamination and release of the material contained.(TR28) (TR 66)
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Aseptic Processing Area (APA)
Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)
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Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)
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