SOP for Entry/Exit in Sterile Area
Title: Standard Operating Procedure for Entry/Exit in Sterile Areas
Objective: To establish clear procedures for personnel entering and exiting sterile areas to prevent
contamination.
Scope: This SOP applies to all personnel entering and exiting sterile areas within the facility.
Responsibilities:
Sterile Area Supervisor: Oversees entry and exit procedures.
All Personnel: Responsible for following the entry and exit procedures.
Procedure:
General Entry/Exit Procedures:
All personnel must undergo training on entry and exit procedures.
Adhere to gowning and hygiene requirements before entering sterile areas.
Remove personal items, such as jewelry and watches, before gowning.
Perform hand hygiene using approved methods.
Gowning and Attire:
Wear designated sterile attire, including gowns, gloves, masks, and hairnets.
Ensure that gowns are properly secured and cover all exposed skin.
Access Control:
Use access control systems (e.g., key cards) to enter sterile areas.
Access is restricted to authorized personnel only.
Entry Sequence:
Enter sterile areas through designated entrances.
Do not enter sterile areas simultaneously with another person unless required.
Exiting Sterile Areas:
Exit sterile areas through designated exits.
Remove and dispose of personal protective equipment (PPE) properly.
Personal Items:
Personal items like pens, notebooks, and mobile phones are not allowed inside sterile areas.
Use designated storage areas for personal items.
Emergency Situations:
In case of emergency exits, follow evacuation procedures.
Notify a supervisor or safety personnel immediately.
Training:
Ensure that all personnel receive training on entry and exit procedures.
Maintain training records.
Audit and Compliance:
Conduct periodic audits to ensure compliance with entry and exit procedures.
Address audit findings and implement improvements.