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Introduction
This management system establishes protocols for clean room operations in radiopharmaceutical production plants. Strict adherence ensures product sterility, personnel safety, and regulatory compliance.
Scope
Applies to all personnel, equipment, and procedures within radiopharmaceutical production clean rooms.
Objective
Prevent contamination, ensure product integrity, and maintain radiation safety standards.
Critical Components
- Air purification systems
- Personnel protocols
- Environmental monitoring
1Preparation Before Production
a Surface Cleaning
Thoroughly wipe floors, work surfaces, control cabinets, and all dust-prone areas with wet clean cloths.
b Air Purification
Activate air purification system with UV sterilization for minimum 1 hour before production.
c Entry Protocol
Personnel may enter only after 1 hour of air purification system operation.
d Material Transfer
Transfer production materials through designated logistics ports after thorough cleaning.
e Personnel Attire
- Wear clean room-specific garments and footwear
- Cover all hair, beards, and feet completely
- Wear masks covering nose and mouth
- Shower before entry
f Personal Hygiene
- No makeup, jewelry, or accessories
- Maintain short hair and nails
- No entry for personnel with infections or skin conditions
g Environmental Checks
Verify temperature, humidity, and pressure differentials meet requirements. Document readings before production.
Radiopharmaceuticals Journey: Properties and Limitations
Figure 1: Radiopharmaceutical Production Plant
2Requirements During Production
aAir System Operation
Air purification system must remain operational throughout production.
bDoor Management
All doors between clean/non-clean areas must remain closed. Ensure tight sealing after each entry/exit.
cUV Light Protocol
Deactivate UV lights during personnel presence to prevent exposure damage.
dAccess Control
Only essential personnel permitted. Non-production visitors must wear full clean room attire.
eMovement Restrictions
Minimize movement to prevent particle generation and shedding. Maintain deliberate, controlled motions.
Autoclaves for Clean Rooms
Figure 2: Clean Room Work Requirements
3Post-Production Procedures
aCleanup & Organization
Thoroughly clean used areas and organize all items. Return equipment to designated locations.
bMaterial Management
- Clean all used production items
- Log items remaining in or removed from clean room
- Remove personal items and waste promptly
cPower Management
Deactivate all non-essential power sources and lighting systems.
dSecuring the Area
Close and lock all clean room doors according to security protocols.
eSystem Shutdown
Deactivate air purification system and complete operational logs.
Clean Room Door Selection
Figure 3: Clean room environment Requirements
4Critical Precautions
aConsumption Ban
Strictly prohibit eating, drinking, or smoking in clean room areas.
bBehavior Standards
Prohibit disruptive behavior, loud noises, or running in Clean room environments.
cAttire Regulations
Clean room garments restricted to clean areas only. Never wear personal clothing in clean rooms.
dPest Prevention
Ensure all doors remain securely closed to prevent insect or rodent contamination.
eWaste Management
Properly dispose of all waste materials. No littering in any facility areas.
fStorage Areas
Maintain clutter-free changing rooms. Keep lockers closed when not in use.
gChanging Protocol
Change into clean room attire only in designated changing areas.
hRadioactive Safety
Avoid touching door handles with gloved hands to prevent radioactive contamination.
5Visitor Management Protocol
Authorization Process
- All visitor requests require General Manager approval
- Department leaders must verify authorization
- Unauthorized requests must be declined
Visitor Attire
Visitors must wear clean room-specific garments and footwear before entry, including passage through air shower.
Information Restrictions
- No disclosure of production process secrets
- Prohibit photography or equipment sketching
- Team leaders must intervene if violations occur
Enforcement Protocol
Team leaders must refuse entry to improperly attired visitors and report unauthorized access requests to department leadership.
Clean Room Manufacturing Standards
Figure 4: Visitors in Clean Room
6Compliance Enforcement
Violation Penalties
50 RMB fine per violation, allocated to department activity fund
Reporting Protocol
Verified reports of violations result in penalty allocation to the reporter
Documentation
All violations and penalties recorded in department compliance log
Sterility is Our Responsibility
Adherence to these protocols ensures product safety, regulatory compliance, and protection of both personnel and patients.
