INTRODUCTION:
Maintaining a contamination-free environment is essential in a microbiology laboratory, especially in pharmaceutical and healthcare settings where microbial control is critical. The Single Door Entry system is a fundamental architectural and procedural design element aimed at ensuring controlled access, unidirectional personnel flow, and environmental integrity.
This entry system helps prevent cross-contamination between classified and unclassified areas by enforcing strict access control and gowning protocols before entering critical zones. It supports compliance with GMP, WHO, and Schedule M guidelines, and forms an integral part of the facility’s biosafety and cleanroom management strategy.
By allowing access through one controlled point, the Single Door Entry concept enhances microbial containment, supports proper air pressure maintenance, and reduces the risk of human error in high-sensitivity microbiological operations.
Risk-Assessment-of-Single-Door-Entry-in-a-Microbiology-LaboratorySingle Door Entry – Microbiology Laboratory
Purpose:
To ensure unidirectional personnel flow and prevent cross-contamination between classified and non-classified areas.
Key Requirements:
- Controlled Access:
- Only authorized personnel allowed.
- Access via biometric/RFID/card entry system preferred.
- Gowning Protocol:
- Entry door should lead to a gowning/anteroom.
- Gowning must comply with cleanroom classification standards (ISO/GMP).
- Pressure Differential:
- Maintain appropriate pressure cascade to prevent ingress of contaminants.
- Pressure indicators must be placed at entry.
- Air Handling System:
- Door must be integrated with AHU interlocks or airlocks to maintain HEPA-filtered airflow integrity.
- Material and Personnel Separation:
- Entry must not double as a material transfer route.
- Personnel and material movement must be clearly separated.
- Interlocking System (if applicable):
- Prevent simultaneous opening of adjacent doors.
- Supports air pressure maintenance and contamination control.
Not Allowed:
- Back-and-forth movement without following gowning/de-gowning protocols.
- Bypassing entry protocols through emergency exits or shared doors.
- Using single door entry as a material entry or exit point.
Why It Matters:
- Maintains sterility and integrity of microbiology operations.
- Minimizes risk of environmental or sample contamination.
- Ensures compliance with GMP, WHO, and Schedule M guidelines.