| Sr. |
Topics |
Clean Room |
cRABS |
Isolator |
| 1 |
Physical Attributes |
Cleanroom |
Hard walled (Non metallic and semimetailc framing), Glove port, HEPA filters, transfer ports. |
Hard walled metalic with glass view panel. Glove port, HEPA filters, transfer ports. |
| 2 |
Surrounding Classification |
ISO 7 (HEPA Filtration) |
ISO 07 |
ISO 08 |
| 3 |
Air Handling |
Room : HVAC |
Room HVAC or equipment's own for air handling. Open to clean room atmosphere, inlet or exhaust in /from clean room. |
Our equipment's for air handling. Leak tight out side ventilation. |
| 4 |
Sanitization |
Manual |
Manual |
Automatic / Manual |
| 5 |
Environment Monitoring |
Portable |
Portable or Built in. |
Built in |
| 6 |
Gowning Comfort |
Standard (Cleanroom garments) |
Clean room garments and glove port usage. |
Simple growing but gloveport usage. |
| 7 |
Glove Testing |
Not applicable |
Required |
Required |
| 8 |
Training and Support |
Standard (Many simple SOPs to be learned) |
Higher, SOPs and handling of transfer ports and glove ports required. |
Highest, SOPs and handling of transfer ports and glove ports, understanding of automated programmes, biodecontamination, system software training required. |
| 9 |
Feasibility for Potent Drugs |
Closed process or high PPE required. |
Limited OEL requirement can be met with containment. |
Absolute containment as per ISO |
| 10 |
Validation Effort |
Standard |
Higher (For Transfer and intervention.) |
Highest (Required for transfer, biodecontamination process technology.) |
| 11 |
Software and data effort |
Standard |
Standard ( Only for door inter locking.) |
High( More complex because integrated, automated process technology.) |
| 12 |
Turn around Time |
Short |
Longer (more surfaces to be decontaminated/disinfected and time consuming material transfer processes.) |
Longest (Biodecontamination process cycle time. CIP-SIP and loading EM media.) |
| 13 |
Aseptic quality |
Standard |
Improved barrier |
Highest (barrier and efficient biodecontamination process.) |
| 14 |
Flexibility |
Standard |
Medium (Doors closed during production but easy part changes.) |
Lower (time constant because of biodecontamination and CIP-SIP.) |
| 15 |
Operational Cost for new facility |
Highest |
High (RABS need clean room atmosphere for installation and air handling and operation.) |
Significantly lower (Saving for gowning, equipment usage, clean room area, HVAC.) |
| 16 |
Types |
Standard |
Active / Passive. |
Positive / Negative |
Comparison between various Containment Strategies.