The Proven Efficacy of the Airocide Mobile
Situation
Maintaining optimum air quality is a critical requirement in pharmaceutical compounding areas to comply with regulatory standards and ensure the safety and efficacy of compounded preparations. The Airocide Mobile has been recognized in air sampling reports as a viable solution to address concerns regarding airborne viables in compounding pharmacies. Currently, over 1,000 hospitals nationwide have implemented the S400 to optimize their air quality.
Technology
The Airocide Mobile's portable medical-grade air-purification system uses a proprietary 3-stage technology to effectively destroy airborne microorganisms.
- Medical Grade HEPA Filter: Captures a large volume of airborne contaminants.
- Active Carbon Substrata: Captures and suspends particulates that move past the HEPA filter, and facilitates VOC removal.
- UV-C 254nm Bulbs: Inactivate and destroy microscopic pathogens.
Performance Metrics
The Airocide Mobile's digital display provides real-time data on in-room airflow and quality, crucial for monitoring and maintaining clean room standards. It has displayed its capability to significantly reduce viable and non-viable particulates in the air and on surfaces.
Ease of Implementation
The Airocide Mobile requires no installation, ensuring a seamless integration into the existing infrastructure of healthcare settings, including compounding pharmacies.
Impact
Key hospitals have trialed the Airocide Mobile and successfully transitioned their compound pharmacy areas from ISO 8 to ISO 7 or higher by reducing air and surface viables. The pre- and post-trial certification reports displayed a remarkable improvement in particle count locations, viable sampling, and actionable microorganisms, affirming the Airocide Mobile efficacy.
Conclusion
The Airocide Mobile presents a robust solution for compounding pharmacies aiming to enhance air quality and achieve compliance with USP 797 and ISO certification standards, thereby contributing to better patient safety and overall pharmaceutical care quality.
Testing Before Airocide Mobile
| Sample Location | Class | Pass | Acpt | O.O.C | Cause |
|---|---|---|---|---|---|
| 1A I.V. Room | 7 | ✓ | |||
| 2A Passthrough #1 (Double Interlock) | 7 | ✓ | |||
| 3A Ante Room | 7 | ✓ | |||
| 4A Ante Room | 7 | ✓ | |||
| 5A Passthrough #2 (Double Interlock) | 8 | ✓ | |||
| 6A Chemo Room | 7 | ✓ | |||
| 7A BVBI-6SS-RX (S#6S-15-BVBI-16574) | 5 | ✓ | |||
| 8A BZ-655-RX (65-15-BH-16573) | 5 | ✓ | |||
| 9A NV-425-400 (105725041106) | 5 | ✓ | |||
| 1B I.V. Room | 7 | ✓ | |||
| 2B Passthrough #1 (Double Interlock) | 7 | ✓ | |||
| 3B Ante Room | 7 | ✓ | |||
| 4B Ante Room | 7 | ✓ | Maximum cont for Class 7 exceeded | ||
| 5B Passthrough #2 (Double Interlock) | 8 | ✓ | |||
| 6B Chemo Room | 7 | ✓ | Maximum cont for Class 7 exceeded | ||
| 7B BVBI-6SS-RX (S#6S-15-BVBI-16574) | 5 | ✓ | |||
| 8B Z-6SS-RX (6S-15-BH-16573) | 5 | ✓ | |||
| 9B NV-425-400 (105725041106) | 5 | ✓ |
Lab Sample #: 18021805-013
Sample Location: Client Sample# 4B
Test: 1108, USP 797 Culture, Air, Fungal Counts with ID: SOP 3.2 Positive Hole
Corrected Result: 2 CFU/m³
Organism(s) Isolated: Bacillus species Non-sporulating colony
| Raw Count | CFU/m³ | % TOTAL | MRL |
|---|---|---|---|
| 1 | 1 | 50 | 1 |
| 1 | 1 | 50 | |
| 2 | 2 | ~100% | 1 |
Lab Sample #: 18021805-015
Sample Location: Client Sample# 6B
Test: 1108, USP 797 Culture, Air, Fungal Counts with ID: SOP 3.2 Positive Hole
Corrected Result: 1 CFU/m³
Organism(s) Isolated: Aspergillus flavus
| Raw Count | CFU/m³ | % TOTAL | MRL |
|---|---|---|---|
| 1 | 1 | 50 | 1 |
| 1 | 1 | 50 | |
| 1 | 1 | ~100% | 1 |
COMMENTS O.O.C. 1 CFU/m³
Sample was incubated for 7 days at 26 °C. Bacteria colonies counted on MEA plate per client request.
Positive Hole: 300 Air Volume: 1000 (L) MRL: 1
Testing After Airocide Mobile
| Sample Location | Class | Pass | Acpt | O.O.C | Cause |
|---|---|---|---|---|---|
| 1A I.V. Room | 7 | ✓ | |||
| 2A Passthrough #1 (Double Interlock) | 7 | ✓ | |||
| 3A Ante Room | 7 | ✓ | |||
| 4A Ante Room | 7 | ✓ | |||
| 5A Passthrough #2 (Double Interlock) | 8 | ✓ | |||
| 6A Chemo Room | 7 | ✓ | |||
| 7A BVBI-6SS-RX (S#6S-15-BVBI-16574) | 5 | ✓ | |||
| 8A BZ-655-RX (65-15-BH-16573) | 5 | ✓ | |||
| 9A NV-425-400 (105725041106) | 5 | ✓ | |||
| 1B I.V. Room | 7 | ✓ | |||
| 2B Passthrough #1 (Double Interlock) | 7 | ✓ | |||
| 3B Ante Room | 7 | ✓ | |||
| 4B Ante Room | 7 | ✓ | No growth of microorganisms. Compliance with USP 797 and CAG-009 | ||
| 5B Passthrough #2 (Double Interlock) | 8 | ✓ | |||
| 6B Chemo Room | 7 | ✓ | No growth of microorganisms. Compliance with USP 797 and CAG-009 | ||
| 7B BVBI-6SS-RX (S#6S-15-BVBI-16574) | 5 | ✓ | |||
| 8B Z-6SS-RX (6S-15-BH-16573) | 5 | ✓ | |||
| 9B NV-425-400 (105725041106) | 5 | ✓ |
Lab Sample #: 18026208-001 (Lot# 118206)
Sample Location: Client Sample# 4B
Test: 1108, USP 797 Culture, Air, Fungal Counts with ID: SOP 3.2
Positive Hole Corrected Result: NO GROWTH
| Raw Count | CFU/m³ | % TOTAL | MRL |
|---|---|---|---|
| 1 | 1 | 50 | 1 |
COMMENTS No Growth
Sample was incubated for 7 days at 26 °C. Bacteria colonies counted on MEA plate per client request.
Positive Hole: 300 Air Volume: 1000 (L) MRL: 1
Lab Sample #: 18026208-002 (Lot# 118206)
Sample Location: Client Sample# 6B
Test: 1108, USP 797 Culture, Air, Fungal Counts with ID: SOP 3.2
Positive Hole Corrected Result: NO GROWTH
| Raw Count | CFU/m³ | % TOTAL | MRL |
|---|---|---|---|
| 1 | 1 | 50 | 1 |
COMMENTS No Growth
Sample was incubated for 7 days at 26 °C. Bacteria colonies counted on MEA plate per client request.
Positive Hole: 300 Air Volume: 1000 (L) MRL: 1
COMMENTS O.O.C. 2 CFU/m³
Sample was incubated for 7 days at 26 °C. Bacteria colonies counted on MEA plate per client request.
Positive Hole: 300 Air Volume: 1000 (L) MRL: 1