Pharmaceutical manufacturing facilities demand exceptional attention to cleanliness, contamination control and maintainability.
Construction joints, wall interfaces, equipment connections and service areas must be carefully detailed to minimize locations where dust, moisture and contaminants can accumulate.
MS-2000 provides a flexible and durable sealing solution for appropriate applications within these demanding environments.
Why Joint Sealing Matters
In controlled manufacturing environments, poorly sealed joints can create:
- Dust traps
- Moisture accumulation
- Difficult-to-clean interfaces
- Maintenance problems
- Potential contamination points
The objective is to create smooth, continuous and maintainable surfaces wherever practical.
FDA 21 CFR 175.300 Testing
MS-2000 has been evaluated according to FDA 21 CFR Part 175.300 for total extractives.
The test report records passing results for extraction using:
| Extraction Medium | Result | Reported Requirement | Result |
|---|---|---|---|
| Distilled Water | 0.2 mg/in² | <18 mg/in² | Pass |
| n-Heptane | 7.9 mg/in² | <18 mg/in² | Pass |
| 8% Alcohol | 0.4 mg/in² | <18 mg/in² | Pass |
Potential Applications
MS-2000 can be considered for appropriate sealing applications such as:
- Clean manufacturing areas
- Equipment interfaces
- Panel joints
- Service penetrations
- Wall interfaces
- Maintenance joints
- Utility-area sealing
Important: FDA 21 CFR 175.300 testing should not be interpreted as general FDA approval of MS-2000 for every pharmaceutical or cleanroom application. The suitability of the complete system must be assessed according to the project’s specifications and regulatory requirements.
Beyond Compliance: Performance
Regulatory suitability alone is not enough.
A professional construction sealant must also provide reliable physical performance.
MS-2000 has demonstrated:
- Adhesion and cohesion under cyclic movement
- Resistance to heat ageing
- Resistance to accelerated weathering
- Adhesion-in-peel
- Non-staining characteristics
For example, the product achieved no loss in bond during Class 50 cyclic movement testing on mortar and aluminium.
pharmaceutical facility sealant, cleanroom sealant, hygienic sealant, pharmaceutical construction sealant, FDA tested sealant, FDA 21 CFR 175.300, clean manufacturing sealant, sanitary joint sealant, low VOC sealant, MS-2000