Basics of Contamination Con trol Basics of Basics of Contamination Contamination Control Control This product was funded by a grant awarded under the President’s High Growth Job This product was funded by a grant awarded under the President’s High Growth Job Training Initiative as implemented by the U.S. Department of Labor’s Employment & Training Initiative as implemented by the U.S. Department of Labor’s Employment & Training Administration. The information contained in this product was created by a Training Administration. The information contained in this product was created by a grantee organization and does not necessarily reflect the official position of the U.S. grantee organization and does not necessarily reflect the official position of the U.S. Department of Labor. All references to non-governmental companies or organizations, Department of Labor. All references to non-governmental companies or organizations, their services, products, or resources are offered for informational purposes and their services, products, or resources are offered for informational purposes and should not be construed as an endorsement by the Department of Labor. This product is should not be construed as an endorsement by the Department of Labor. This product is copyrighted by the institution that created it and is intended for individual copyrighted by the institution that created it and is intended for individual organizational, non-commercial use only organizational, non-commercial use only
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Basics of Contamination Control
Basics of Basics of Contamination Contamination
ControlControl
This product was funded by a grant awarded under the President’s High Growth Job Training This product was funded by a grant awarded under the President’s High Growth Job Training Initiative as implemented by the U.S. Department of Labor’s Employment & Training Administration. Initiative as implemented by the U.S. Department of Labor’s Employment & Training Administration.
The information contained in this product was created by a grantee organization and does not The information contained in this product was created by a grantee organization and does not necessarily reflect the official position of the U.S. Department of Labor. All references to non-necessarily reflect the official position of the U.S. Department of Labor. All references to non-
governmental companies or organizations, their services, products, or resources are offered for governmental companies or organizations, their services, products, or resources are offered for informational purposes and should not be construed as an endorsement by the Department of Labor. informational purposes and should not be construed as an endorsement by the Department of Labor.
This product is copyrighted by the institution that created it and is intended for individual This product is copyrighted by the institution that created it and is intended for individual organizational, non-commercial use only organizational, non-commercial use only
Basics of Contamination Control
AudienceAudience ManufacturingManufacturing Quality ControlQuality Control Quality Quality
AgendaAgenda Define Contamination ControlDefine Contamination Control
Sources of ContaminationSources of Contamination Review Regulations Relating to Review Regulations Relating to
Contamination Control Contamination Control 21 CFR Part 21121 CFR Part 211
Components of a Contamination Control Components of a Contamination Control Program Program
Best Practices in Developing & Best Practices in Developing & Maintaining a Contamination Maintaining a Contamination Control ProgramControl Program
Review CitationsReview Citations
Basics of Contamination Control
Training GoalsTraining Goals To provide participants the information To provide participants the information
that will aid in establishing and that will aid in establishing and maintaining a Contamination maintaining a Contamination
Control Program.Control Program. Gain a better understanding of the Gain a better understanding of the
aspects of product manufacturing aspects of product manufacturing that have the potential to that have the potential to contribute to product contribute to product contamination.contamination.
Make employees aware of areas they Make employees aware of areas they can assist in reducing the potential can assist in reducing the potential
of product contaminationof product contamination
Basics of Contamination Control
What is Contamination What is Contamination Control?Control? DefinitionDefinition
Proactive prevention of contaminationProactive prevention of contamination Contamination is considered any foreign Contamination is considered any foreign environmental, chemical and biological environmental, chemical and biological
matter.matter. To ensure:To ensure:
Product free of foreign matterProduct free of foreign matter Appropriate control measures exist to Appropriate control measures exist to
prevent product contamination. prevent product contamination. Environments & product contact areas do Environments & product contact areas do
not contribute to product not contribute to product contaminationcontamination
Gowning practicesGowning practices Materials/containers/closures do not Materials/containers/closures do not
contribute to product contamination contribute to product contamination Appropriate documentation system of Appropriate documentation system of
Notes: Number of particles per cubic meter (m3) or ft3
Basics of Contamination Control
Sources of Sources of ContaminationContamination
People - Greatest FactorPeople - Greatest Factor General hygiene, microbiology, poor clean/ General hygiene, microbiology, poor clean/
controlled room controlled room practices, unhealthy, untrained, practices, unhealthy, untrained, not following procedures etc. not following procedures etc.
Basics of Contamination Control
Sources of Sources of ContaminationContamination PeoplePeople
Ensure product safetyEnsure product safety Data to support satisfactory Data to support satisfactory
operation of facility, operation of facility, equipment quality systemsequipment quality systems Validation, Statistical Process Validation, Statistical Process
Control (SPC) & Proof Control (SPC) & Proof that we do itthat we do it
Confirm absence of objectionable Confirm absence of objectionable organisms organisms
Equipment design, construction Equipment design, construction & maintenance & maintenance
211.84 Testing and approval or 211.84 Testing and approval or rejection of components, rejection of components, drug product containers, and closuresdrug product containers, and closures
211.113 Control of microbiological 211.113 Control of microbiological contaminationcontamination
211.146 Ventilation, air filtration, 211.146 Ventilation, air filtration,
air heating and coolingair heating and cooling 211.165 Testing and release for 211.165 Testing and release for
distributiondistribution
Basics of Contamination Control
Components of a Contamination Components of a Contamination Control ProgramControl Program
maintenance procedures maintenance procedures Cleaning historyCleaning history Maintenance historyMaintenance history Compatibility of cleaning agentsCompatibility of cleaning agents Confirm removal of cleaning agentConfirm removal of cleaning agent
Process of bringing contamination to a safe Process of bringing contamination to a safe level typically applies to cleaning of level typically applies to cleaning of inanimate objectsinanimate objects
Facility Design & Facility Design & Process FlowProcess Flow
Materials ManagementMaterials Management Well written Policies & Well written Policies &
Standard Operating Standard Operating Procedures (Controlled Procedures (Controlled Documents)Documents)
TrainingTraining
Basics of Contamination Control
Basics of Contamination Control Basics of Contamination Control SummarySummary
FDA expects systems to support proactive contamination control Standard operating procedures (SOPs) & data to
support the systems designed to monitor and control the environment;
Sanitation practices Cleaning & disinfecting of facility & equipment
surfaces Facility Design and Process Flow Good hygiene, gowning practices & clean room behavior Evaluation of incoming materials, containers & closures Controlled processes for movement of materials to and from clean rooms Product evaluation and testing of in-process and