Rigor Instruments’ Clean Room: Specifications & Compliance
Ensuring Sterile Precision for World-Class Surgical Instruments
At Rigor Instruments, we understand that the final phase of surgical instrument manufacturing—cleaning, inspection, and packaging—must meet the highest global standards. That’s why we operate a state-of-the-art clean room, designed to ensure absolute sterility, precision, and compliance with international regulatory norms.
Clean Room Overview
| Feature | Specification |
|---|---|
| Clean Room Class | ISO 7 (Class 10,000) |
| Total Area | 300 square feet (expandable to 600 sq. ft.) |
| Usage | Final inspection, ultrasonic drying, and medical-grade packaging |
| Filtration | HEPA filters (99.97% @ 0.3 micron) |
| Air Changes per Hour | 60–90 ACH |
| Temperature Control | 21–23°C (maintained) |
| Humidity Control | 45–55% RH |
| Lighting | 500 lux anti-glare, sterile-grade lighting |
| Surfaces | Anti-microbial epoxy flooring, stainless steel benches |
| Staff Protocol | Full gowning (coveralls, gloves, shoe covers, masks, hair nets) |
| Monitoring | Digital particle counter, pressure monitoring, and access control |
Compliances Met
ISO 13485:2016 – Medical device manufacturing quality management
ISO 14644-1 – Cleanroom classification
CE Marking Packaging Requirements
US FDA 21 CFR Part 820
Clean Room Activities
Post-ultrasonic drying
Visual and magnified inspection
Laser marking
Packaging into sterile barrier systems
Final sealing and batch coding
Why Our Clean Room Sets Us Apart
Many manufacturers in Pakistan skip this step or outsource packaging to third parties. At Rigor Instruments, our in-house clean room guarantees:
Full traceability
Zero bioburden
Sterility protection
Better client and regulatory confidence
The Hidden Risks of Skipping Clean Room Packaging in Surgical Instruments
Why Rigor Instruments Invests in Sterile Environments—So Patients Don’t Pay the Price
Final packaging is not just a formality—it is the last line of defense between a surgical instrument and the patient. Skipping a controlled clean room during this process exposes both healthcare professionals and patients to serious risks.
Here’s what’s at stake when instruments are not packed in ISO-compliant clean rooms:
1. Microbial Contamination
Without HEPA-filtered air and controlled environments:
Dust, bacteria, and spores can settle on instruments
Contaminated tools can cause post-operative infections, even if they’re sterilized later
Especially dangerous in orthopedic, neurosurgery, or implant procedures
2. Cross-Contamination
Handling instruments in non-clean zones may introduce foreign biological particles, human skin cells, or textile fibers
Can lead to sepsis, delayed wound healing, and even litigation
3. Packaging Seal Failure
In uncontrolled environments:
Moisture and particulate matter can weaken packaging seals
Packaging may fail during sterilization (autoclave or ETO), leading to instrument rejection
Hospitals may unknowingly use non-sterile packs, compromising surgical protocols
4. Reduced Shelf Life
Instruments packed outside clean rooms are more prone to moisture absorption, corrosion, and dust retention
This reduces shelf life, especially for exported or long-storage instruments
5. Regulatory Non-Compliance
CE, ISO 13485, and FDA guidelines require validated cleanroom conditions for Class I/II surgical instruments
Instruments packaged outside cleanrooms may face:
Customs rejection
Loss of tenders
Recall risks
Legal action for negligence
Why Rigor Instruments Always Uses Clean Rooms
We operate a fully equipped ISO 7 clean room with:
HEPA filtration (99.97% purity)
Controlled air pressure, humidity, and temperature
Anti-static, anti-microbial flooring
Proper gowning and trained personnel
Full traceability from sterilization to packaging
This ensures every Rigor instrument is delivered contamination-free, sterile-ready, and globally compliant.
Bottom Line:
If the final packaging is compromised, so is the patient’s safety.
That’s why Rigor Instruments never compromises—and educates clients to recognize the difference.
📩 Want to learn how to audit your current supplier’s packaging standards?
Email us: [email protected]
WhatsApp: +92 303 7759000
🌐 www.rigorinstruments.com
