by Richard A. Matthews
Biocontamination = contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles.
Viable particle = particle that consists of or supports one or more live organisms.
People = objects that generate viable particles.
As part of our continuing look at the new global cleanroom standards, this month we focus on the subject of biocontamination control in cleanrooms.
Originally the ISO/TC209 committee created a package of three standards on biocontamination control. This has been subsequently revised to two standards and one technical report.
TITLE: Cleanrooms and associated controlled environmentsBiocontamination control Part 1: General principles and methods.
SCOPE: Describes the principles and basic methodology for a formal system to assess and control biocontamination in cleanrooms.
STATUS: FDIS (Final Draft International Standard) document is awaiting issue by ISO Geneva for an FDIS vote by all the member ISO nations.
As we increase international trade in hygiene-sensitive products, there is a strong requirement for stable and safe products, particularly in the healthcare field.
Achieving this stability and safety requires control of biocontamination in the design, specification, operation and control of cleanrooms and associated controlled environments. ISO 14698-1 is a 28-page document that provides guideline principles for establishing and maintaining a formal system to assess and control biocontamination in these special environments.
A formal system of biocontamination control will assess and control factors that can affect the microbiological quality of a process or product. There are a number of formalized systems to achieve this, such as Hazardous Analysis Critical Control Point (HACCP), Fault Tree Analysis (FTA), Failure Mode and Effect Analysis (FMEA) and others.
ISO 14698-1 is concerned only with a formal system to address microbiological hazards in cleanrooms. Such a system must have the means to identify potential hazards, determine the resultant likelihood of occurrence, designate risk zones, establish measures of prevention or control, establish control limits, establish monitoring and observation schedules, establish corrective actions, establish training procedures, and provide proper documentation.
It is the user's responsibility to develop, initiate, implement and document a formal system for biocontamination controlone that enables detection of adverse conditions in a timely fashion. Certain regulatory authorities will have significant impact on this responsibility.
Target, alert and action levels must be determined for a given risk zone. Such levels will determine the required remediation effort. All of these impact product quality.
A biocontamination sampling program must be established for cleanroom air, walls, floors, ceilings, process equipment, raw materials, process liquids and gases, furniture, storage containers, personal attire and protective clothing. Sampling frequency, site location, sample identification, culturing methods and evaluation criteria must be included.
This formal system becomes a key part of the validation process for a cleanroom or associated controlled environment.
ISO-14698-1 provides detailed guidance on how to measure airborne biocontamination, how to validate air samples and how to measure biocontamination of surfaces, liquids and textiles used in cleanrooms; it also provides guidance for validating laundering processes and how to provide proper personnel training.
Train your personnel to properly wash their hands. If they do not, the consequences to your customers could be deadly. People are significant carriers and dispensers of biocontamination.
ISO 14698-1 has a close companion document ISO 14698-2, which provides guidance on the evaluation and interpretation of biocontamination data.
TITLE: Cleanrooms and associated controlled environmentsBiocontamination control Part 2: Evaluation and interpretation of biocontamination data.
SCOPE: Gives guidance on basic principles and methodology requirements for all microbiological data evaluation obtained from sampling for viable particles in specified risk zones in cleanrooms.
STATUS: FDIS document is awaiting issue by ISO Geneva for an FDIS vote by all the member ISO nations.
Determining the presence and significance of biocontamination is a multi-step task.
Sampling techniques, time factors, culturing techniques and analysis method (qualitative or quantitative estimates) all have to be carefully planned. Target, alert and action levels have to be determined for each risk zone based upon an initial biocontamination data collection and evaluation plan.
Each enumeration technique must be validated considering the viable particles involved.
Good data collection and evaluation documentation is necessary to determine trend analysis and the quality of risk zones. Out-of-specification results require verification. “Did we have a true result or is it a laboratory error?” ISO 14698-2 provides the guidance for answering this question accurately.
TITLE: Cleanrooms and associated controlled environmentsBiocontamination control Part 3: Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontamination wet soiling or biofilms.
SCOPE: Describes guidance for a laboratory method for measuring the efficiency of cleaning an inert surface.
STATUS: Passed an ISO DIS (Draft International Standard) vote in July 1999. Has been subsequently determined to be too limiting to be issued as an ISO Standard.
The ISO Technical Committee ISO/TC209 determined at its May 2000 meeting to issue ISO 14698-3 as an ISO Technical Report. It will be available for informational purposes only. It will not become an ISO Standard.
These documents may be purchased for a nominal fee from the Institute of Environmental Sciences and Technology (IEST), 940 East Northwest Highway, Mt. Prospect, IL 60059. Phone: 847-255-1561; Fax: 847-255-1699 or www.iest.org.
Richard A. Matthews is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments.”