CSSD Module 9: Inspection, Assembly, and Packaging (IAP)

Inspection, Assembly, and Packaging (IAP) Area

• The IAP area is a clean area in the CSSD where surgical instruments are inspected for intactness, cleanliness, and functionality.
• Trained decontamination specialists and technicians handle the instruments in this area according to the manufacturer's IFU.
• The area is designated and controlled to optimize sterilization and minimize contamination risk.

Environmental Requirements for IAP

• Ventilation meets clean room standards according to ISO 14644-1:1999 Class 8 or equivalent international standards.
• The room is maintained under positive pressure to ensure air flows outward when doors are opened.
• The environment is kept at 20-23°C with a relative humidity of 30-60%.
• Environmental cleaning follows approved hospital policies and procedures.
• Furniture is made of smooth, non-porous, easy-to-clean materials.
• Shoes must be worn with protective covers to prevent contamination.

Washer-Disinfector (WD) to Sterilizer

• Clean, disinfected surgical instruments and accessories are unloaded from the washer-disinfector.
• Automated or manual unloading processes are used, depending on the equipment.
• Quality checks are performed before further processing, including:
  • Correct cycle selection
  • Spray arms not blocked
  • No soil or staining
  • Correct operating cycle
  • Visual inspection for damage, staining, or residue
  • Visual inspection for dryness

Manually Cleaned Device Acceptance

• Quality checks are also performed for manually cleaned devices, including:
  • No visible soil or staining
  • Items must be dry before moving to the IAP room
  • No damage or incorrect handling
  • Correct disassembly
  • Documentation completed

Inspection and Function Testing

• Surgical devices are inspected for cleanliness, stains, corrosion, cracks, breakage, and stiffness of movable parts.
• Devices are inspected under magnification where possible.
• Each RMD is inspected separately, including:
  • Box joints, serrations, and crevices
  • Hinges and movable parts
  • Jaws and teeth alignment
  • Ratchets and easy closure
  • Cannulated devices for patent channels
  • Function testing of telescopes and light cables
  • Completeness of device sets
  • Cutting edges for sharpness
  • Insulated devices for intact insulation
  • Free movement of all parts and non-sticking joints
  • Water-based lubricant use (if required)

Assembly and Checking

• Devices are assembled into their respective trays after inspection and function testing.
• Computerized track and trace systems are used to track devices and device trays through the decontamination process.
• The system includes handheld barcode readers, PCs, and packing lists with unique barcode labels.
• A manual system may be used in the absence of a computerized system.