Compliance Audit Program
During a CAP inspection, various aspects of the laboratory's operations and management are evaluated, including procedure manuals, completeness of records, types and methods of quality control and factors that indicate that the lab is meeting high-quality standards.
Contract Development Manufacturing Operations
A colony-forming unit (CFU, cfu, Cfu) is a unit used in microbiology to estimate the number of viable bacteria or fungal cells in a sample. Viable is defined as the ability to multiply via binary fission under the controlled conditions. Counting with colony-forming units requires culturing the microbes and counts only viable cells, in contrast with microscopic examination which counts all cells, living or dead. The visual appearance of a colony in a cell culture requires significant growth, and when counting colonies it is uncertain if the colony arose from one cell or a group of cells. Expressing results as colony-forming units reflects this uncertainty.
A designated space that is closely controlled for compliance to limitations that have been outlined for operating procedures, air cleanliness, air pressure, temperature, relative humidity, and air flow patterns. A number of devices and procedures are often used in a cleanroom to monitor the viability of airborne particles.
Non-shedding apparel that is designed specifically to serve as a barrier between cleanroom environments and possible contaminants released by cleanroom workers. Cleanroom garments may include footwear, shoe covers, coveralls, gowns, smocks, gloves, face masks, and head coverings.
Cleanroom classification – Grade A, B, C or D
Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian countries. Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations. These Grades can be related to the ISO Classes.
Cleanroom classification – ISO Class
Classification system used to determine the acceptable concentration of particles in an identified volume of air given specific particle size parameters. Classification levels are determined by the federal government. The primary authority in the US and Canada is the ISO classification system ISO 14644-1. This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8.
A space or system of spaces in which there are tightly controlled limits that govern air flow, air pressure, air filtration, temperature, relative humidity, viability of airborne particles, access, and operating procedures.
Cleanroom Facility - As Built
Cleanroom facility that is prepared for operation in terms of construction and systems but without staff present or manufacturing equipment in place.
Cleanroom Facility - At Rest
Cleanroom facility that is fully equipped for operation with the exception of staff on site.
Cleanroom Facility - In Operation
Cleanroom facility that is equipped and staffed for full operations, with all staff, equipment, and supplies present.
Cleanroom and Controlled Environment Consulting.
In the pharmaceutical industry, one term is becoming increasingly important: containment. It describes the process of containing a substance within a defined space, a method that is suitable for protecting operators and the environment in case of high toxicity and product reactivity. At the same time, containment prevents dust, gases or vapours from being released into the environment and contaminating the product.