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ISPE Japan Affiliate: Pest Control Manual [English Translation] cover image

ISPE Japan Affiliate: Pest Control Manual [English Translation]

Published:August 2018

Pages:180

The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.

With numerous examples of issues often found in older facilities, the Manual describes monitoring and inspection techniques, providing practical approaches for mitigation and remediation. In addition, it contains an extensive pictorial library of pests, including their ecology and environmental indicators, which will assist pharmaceutical manufacturing sites in their pest control monitoring program.

This Manual was edited by the ISPE Japan Affiliate Factory Auxiliary Issues Subcommittee in the Manufacturing Management Community of Practice (CoP) and reviewed by the ISPE Guidance Document Committee

Target building and facility areas covered in this Manual include:

  • Areas where raw materials and products are received, dispatched from, and stored
  • Areas where raw materials and products are inspected, weighed, processed, and packaged
  • Areas where specimens are stored and tested
  • Areas where personnel change clothes and take breaks
  • Outdoor areas adjacent to buildings where pharmaceuticals are handled
  • Machine rooms, water supply facilities, cafeterias, and other areas where waste is stored

  • 1 Introduction
  • 1.1 Purpose of this Manual
  • 2 Scope
  • 2.1 Target Areas (Buildings and Facilities)
  • 2.2 Intended Audience
  • 3 Guidance for Operation
  • 3.1 Pest Control Governance Organization at the Pharmaceutical Manufacturing Site
  • 3.2 Involvement of Pest Control Governance Organization or Construction
  • 3.2.1 Function of Pest Control Governance Organization in Overall Construction
  • 3.2.2 Actions and Points of Concern
  • 3.2.3 Others
  • 3.3 Pest Control Training to Personnel Involved in Construction
  • 3.3.1 Target Attendees
  • 3.3.2 Content of Training
  • 3.3.3 Training Method
  • 3.4 Examples of Installation and Application of Monitoring Traps
  • 3.4.1 Example of the Installation of Traps in Insect Fauna Monitoring
  • 3.4.2 Example of Installation and Application of Traps in Periodic Monitoring
  • 3.4.3 Example of Installation and Application of Traps in Ad hoc Monitoring
  • 4 Buildings and Facilities
  • 4.1 Gaps (Architectural Issues)
  • 4.1.1 Gaps Between Finishing Materials
  • 4.1.2 Around Fittings
  • 4.1.3 Equipment, Floors, and Walls
  • 4.1.4 Others
  • 4.2 Gaps (Facility Issues)
  • 4.2.1 Gap around Wire Penetration Areas
  • 4.2.2 Gap around Pipe Penetration Areas
  • 4.2.3 Gaps around Ancillary Equipment
  • 4.2.4 Gap around HVAC Ductwork
  • 4.2.5 Inspection of Gaps Related to Facility
  • 4.3 Dew Condensation
  • 4.3.1 Basic Knowledge on Dew Condensation
  • 4.3.2 Dew Condensation Related to Architectural Aspects
  • 4.3.3 Dew Condensation Around HVAC Ductwork
  • 4.4 Drainage
  • 4.4.1 Room Drainage System
  • 4.4.2 Indoor Drainpipes
  • 4.4.3 Outdoor Drainage System
  • 4.4.4 Planned Management of Drainage System
  • 4.5 Periphery of Building
  • 4.5.1 Maintenance and Control of Green Spaces around the Building
  • 4.5.2 Measures Against Bird Damage Outdoors
  • 4.5.3 Maintenance of Rooftops
  • 4.5.4 Maintenance of Exterior Walls
  • 5 The Basics on Architectural and Facility Specification
  • 5.1 Caulking
  • 5.1.1 Types and Characteristics of Caulking Materials
  • 5.1.2 Joints
  • 5.1.3 Selection of Caulking Materials
  • 5.1.4 Color of Caulking Materials
  • 5.1.5 Method of Caulking
  • 5.2 Exterior Walls
  • 5.3 Inner Walls (Partition)
  • 5.3.1 Drywall Construction Method
  • 5.3.2 Panel Construction Method
  • 5.4 Baseboards
  • 5.4.1 Overview of Coved Baseboards (R-shaped Baseboards)
  • 5.5 Floors
  • 5.5.1 Types of Floor Finishing Material
  • 5.5.2 Maintenance of Floor Finishing Materials
  • 5.6 Drainage System
  • 5.6.1 Pest Control for the Gutter
  • 5.6.2 Pest Control for Drainage Catch Basin
  • 5.6.3 Drain Traps
  • 5.7 Ventilation
  • 5.7.1 Considerations for HVAC System
  • 5.8 Lighting
  • 5.8.1 Insect-attracting Indexes
  • 5.8.2 LED Light Fixtures
  • 5.9 Air Showers/Pest Control Air Curtains
  • 5.9.1 Air Showers
  • 5.9.2 Pest Control Air Curtains
  • 5.10 Chemical Pest Control
  • 5.10.1 Insecticides
  • 5.10.2 Rodenticides
  • 5.10.3 Examples on the Use of Insecticides and Rodenticides
  • 5.10.4 Caution on the Use of Insecticides and Rodenticides
  • 5.10.5 Cleaning/Disinfecting/Sanitizing of the Facility
  • 5.11 Greening
  • 5.11.1 Greening Measures
  • 6 Insect Library
  • 6.1 Insect Categories
  • 6.2 Insect Library Information Management
  • 6.2.1 Example Creation of an Insect Library in the Pharmaceutical Manufacturing Site
  • 6.3 Insect/Pest References
  • 6.3.1 Invasive Flying Insects
  • 6.3.2 Invasive Crawling Insects
  • 6.3.3 Insects That Occur Indoors
  • 6.3.4 Other Harmful Pests
  • 7 Citations and References
  • 8 Glossary

No Acknowledgments available

No Preface available