Cleanrooms and controlled environments require strict contamination control to protect products, processes, and patient safety. Disinfection is a core component, and it must be effective, validated, and compliant with standards like USP <797>/<800>, EU GMP, and ISO 14644.
Why Disinfection Is Crucial
- Controls microbes (bacteria, fungi, viruses, spores)
- Prevents contamination of sterile drugs and devices
- Ensures compliance with regulatory requirements
- Protects patient and product safety
Common Disinfectants Used in Cleanrooms
Below is a table of the most commonly used disinfectants in cleanroom environments:
| Summary Chart | ||||||
|---|---|---|---|---|---|---|
| Disinfectant | Spectrum | Sporicidal | Residue | Use Frequency | Pros | Cons |
| 70% IPA | Bacteria, viruses | No | No | Daily | Fast, residue-free | Flammable, no sporicidal |
| H202 | Broad | No* | Minimal | Weekly | Low Residue | Can be corrosive |
| Peracetic Acid | Broad incl. spores | Yes | No | Monthly | Very effective | Harsh fumes |
| Bleach (NaOCl) | Broad incl. spores | Yes | Yes | Monthly | Cheap, effective | Corrosive, odor |
| Quats | Bacteria, viruses | No | Yes | Weekly | Mild, surface friendly | Not sporicidal |
| Phenolics | Bacteria, fungi | No | Yes | Rarely | Long-acting | Residual toxicity |
| * Not effective against spores unless combined with other agents. | ||||||
Rotation Strategy
To prevent microbial resistance and meet regulatory expectations:
- Daily: Sterile 70% IPA
- Weekly: Hydrogen Peroxide or Quats
- Monthly: Sporicidal agent (PAA or Bleach)
Tips:
- Clean first, then disinfect
- Follow labeled contact times
- Use sterile, filtered products in ISO 5/GMP Grade A-B areas
Summary
A strong cleanroom disinfection program balances efficacy, safety, and compliance. Use a rotation of disinfectants, including a sporicidal, and apply with validated techniques.
Connect with Technical Safety Services today to keep your cleanroom controlled, compliant, and contamination-free.
