Antistatic & Sterile Coveralls: Compliance, Testing, and What to Ask Your Supplier Before Buying

Introduction: Why Coveralls Are More Than Just Clothing

In cleanrooms and sterile manufacturing areas, garments are not just part of uniform protocol — they’re a critical control barrier between operators and the product.

From sterile injectables to biopharmaceutical manufacturing, a single loose fiber or static discharge can jeopardize an entire batch.

That’s where antistatic coveralls and sterile coveralls come in — designed to prevent contamination, static discharge, and microbial transfer.

In this detailed guide, you’ll learn:

• What makes coveralls compliant with GMP and ISO standards
• How testing (BFE, MFE, and particle shedding) ensures reliability
• Why antistatic properties matter in sterile areas
• What to ask your supplier before buying cleanroom garments

1. Understanding Antistatic & Sterile Coveralls

What Are Antistatic Coveralls?

Antistatic coveralls are garments embedded with conductive fibers that prevent the buildup and discharge of static electricity in controlled environments.

These are critical in:

• Pharmaceutical filling zones
• API manufacturing areas
• Electronic and biotech facilities

Static discharge can attract dust particles or even ignite flammable vapors — making antistatic properties a GMP necessity.

What Are Sterile Coveralls?

Sterile coveralls, on the other hand, are cleanroom garments sterilized (usually via gamma irradiation) and individually packed to maintain aseptic integrity.

They are typically used in:

• Grade A/B cleanrooms
• Aseptic processing and filling lines
• Sterility testing labs

💡 Combination garments — antistatic + sterile coveralls — are now standard for regulated sterile facilities worldwide.

2. Compliance Standards for Antistatic & Sterile Coveralls

Regulators like US FDA, WHO, and EU GMP Annex 1 require cleanroom clothing to meet specific standards of particle control and sterility.

Key Standards

💡 Confianca Pharmazon’s coveralls meet ISO 14644 and EN 1149 standards, validated under controlled gamma sterilization processes.

3. The Science Behind Antistatic Performance

How Antistatic Coveralls Work

Antistatic fabrics incorporate carbon or conductive filaments in a grid pattern across polyester fibers.

These filaments:

• Allow static charges to dissipate safely.
• Prevent dust particle attraction to the fabric surface.
• Minimize electrostatic damage to sensitive instruments or sterile products.

Testing Methods

• Surface Resistance Test (EN 1149-1): Confirms charge dissipation speed.
• Charge Decay Test (EN 1149-3): Measures how fast the charge neutralizes.
• Static Decay Rate (IEC 61340): Evaluates static build-up prevention efficiency.

💡 Look for suppliers providing lab reports showing static charge decay within <0.1 seconds.

4. Sterility and Validation: Gamma Sterilization Explained

Gamma irradiation is the most reliable method to achieve sterility without compromising fabric properties.

Typical Process:

1. Coveralls are packed in double-layer sterile pouches.
2. Irradiated using Cobalt-60 gamma rays (25–40 kGy dose).
3. Sterility validated per ISO 11137 and ISO 11737 (bioburden testing).

Advantages:

• Maintains garment integrity and strength.
• Ensures sterility with minimal thermal stress.
• Provides longer shelf life (up to 3 years).

💡 Ask your supplier for a Sterilization Validation Certificate and COA (Certificate of Analysis) with every batch.

5. Critical Cleanroom Garment Tests (You Must Know)

1. Bacterial Filtration Efficiency (BFE)

Measures the garment’s ability to block bacterial penetration.

• Standard: ASTM F2101 / ISO 22611
• Minimum Requirement: ≥98%

2. Particle Filtration Efficiency (PFE / MFE)

Assesses resistance to airborne micro-particles (0.1–5.0 microns).

• Standard: ASTM F2299
• Minimum Requirement: ≥95%

3. Particle Shedding Test

Evaluates how many particles the fabric releases during motion.

• Standard: IEST-RP-CC003.4
• Result Goal: ≤10 particles ≥0.5µm per cm²

4. Tensile Strength & Tear Resistance

Ensures durability during repeated sterilization cycles.

• Standard: ASTM D5034

💡 Pro Tip: Request test data sheets and ensure the coverall material meets both BFE and MFE ≥98% — ideal for Grade A/B environments.

6. Customization Options for Pharma Companies

Every facility has unique gowning needs depending on its cleanroom class, process type, and gowning SOPs.

Common Customization Options:

• Fabric Type: Polyester + conductive fiber or microporous laminate.
• Color Coding: Blue, white, or grey for zoning segregation.
• Sterilization Option: Gamma sterilized or autoclavable.
• Design Choices:
  • Hooded or non-hooded
  • Elastic wrists and ankles
  • Front zipper or back entry
  • Integrated boot covers

💡 Tip: Choose darker fabric tones for areas with frequent movement — they conceal visible wear and maintain aesthetic consistency.

7. Supplier Checklist: What to Ask Before Purchasing

Before finalizing your supplier for antistatic coveralls, verify these critical points to ensure regulatory compliance and product reliability.

Supplier Evaluation Checklist

✅ 1. Certification & Validation

• Does the supplier provide EN 1149 & ISO 14644 compliance certificates?
• Is sterility validated under ISO 11137 (gamma irradiation)?

✅ 2. COA and Batch Traceability

• Are COAs and batch numbers printed on each package?

✅ 3. Sterile Packaging & Labeling

• Are garments double-packed and labeled “Sterile – Not for Patient Use”?

✅ 4. Testing Documentation

• Can the supplier share BFE, MFE, and particle shedding test reports?

✅ 5. Material Composition Disclosure

• Is fabric antistatic fiber-based or merely coated?

✅ 6. Customization & Sizing

• Can garments be tailored for your cleanroom zoning and process flow?

✅ 7. Shelf Life & Storage

• Are storage conditions and expiry dates clearly defined?

💡 Always request a sample and COA before bulk procurement.

8. Common Mistakes to Avoid When Buying Sterile Coveralls

1. Choosing non-validated suppliers — often leads to audit citations.
2. Ignoring static decay test data — can cause particle attraction issues.
3. Purchasing bulk without COA tracking — risky for audit traceability.
4. Using same garment for multiple zones — cross-contamination risk.
5. Storing garments improperly — shortens shelf life.

Real-World Example: Audit-Ready Coveralls in Action

A sterile injectable facility in Hyderabad faced multiple WHO audit observations due to “inconsistent gowning documentation” and unverified supplier garments.

Confianca Pharmazon Solution:

• Implemented antistatic sterile coveralls validated for BFE, PFE, and gamma sterilization.
• Introduced color-coded garment system for zoning control.
• Provided supplier traceability documents and COAs.

Result:

• Zero garment-related observations in subsequent WHO re-audit.
• Enhanced operator comfort and gowning compliance.

💡 Lesson: Validation-backed garments = effortless audit clearance.

FAQ: Antistatic & Sterile Coveralls

Q1. What’s the difference between sterile and antistatic coveralls?
➡ Sterile coveralls prevent microbial contamination; antistatic coveralls prevent electrostatic discharge and particle attraction. Many facilities use hybrid coveralls combining both.

Q2. How many times can sterile coveralls be reused?
➡ Most are single-use, but some validated reusable garments can undergo limited sterilization cycles if qualified by the manufacturer.

Q3. How are particle shedding tests performed?
➡ Using an air particle counter, particle release is measured under simulated motion conditions as per IEST-RP-CC003.4.

Q4. Are all gamma-sterilized coveralls ISO 11137 compliant?
➡ Only if validated through dose mapping, bioburden analysis, and sterility assurance testing. Always ask for certification.

Q5. Does Confianca Pharmazon supply validated sterile coveralls?
➡ Yes. Confianca provides antistatic and sterile coveralls tested for BFE/MFE, validated under ISO 11137, and supplied with COA and sterility documentation.

Conclusion: Your Garment Is Your Compliance

In pharma manufacturing, gowning isn’t fashion — it’s compliance in motion.

Choosing the right antistatic coveralls and sterile coveralls protects your product, your operators, and your audit reputation.

By verifying certifications, validation data, and sterility testing, you ensure your cleanroom apparel is audit-proof and operator-safe.

👉 CTA: Ready to upgrade your cleanroom garments? Contact Confianca Pharmazon today and ensure GMP-compliant protection.