Pharmaceutical Manufacturer Achieves Cleanroom Excellence with PPE Program

The Challenge

Pain Points

• Particle contamination: Recurring issues in ISO Class 5 areas
• Regulatory pressure: FDA observations on gowning procedures
• PPE waste: Excessive consumption and disposal costs
• Comfort complaints: Workers struggling with heat and mobility
• Inconsistent practices: Variation in gowning across shifts

The Solution

Phase 1: PPE Material Upgrade

ISO Class 5 Areas:

• Sterile, single-use coveralls with low-linting polyethylene fabric
• Integrated hood and booties, sterile gloves with double-gloving protocol

ISO Class 7 Areas:

• Reusable cleanroom coveralls (autoclavable, 25 cycles rated)
• Separate hoods and booties, nitrile cleanroom gloves

ISO Class 8 Areas:

• Reusable frocks or coveralls, laundered cleanroom-grade
• Shoe covers and hair nets, standard cleanroom gloves

Phase 2: Gowning Procedure Redesign

• Step-by-step photographic instructions
• Mirror checkpoints for self-verification
• Buddy system for ISO Class 5 entry
• Initial qualification training (4 hours) with annual requalification

Phase 3: Storage & Handling

• HEPA-filtered storage cabinets
• Individual garment packaging
• First-in-first-out rotation

Results

Contamination Control

Metric	Before	After	Improvement
Particle excursions	8/year	0	100% elimination
Media fill failures	2/year	0	100% elimination
Environmental deviations	24/year	3/year	88% reduction

Cost Optimization

Category	Before	After	Savings
Sterile coveralls	$285K/year	$195K/year	32%
Reusable garments	$120K/year	$78K/year	35%
Gloves	$95K/year	$62K/year	35%
Total	$545K/year	$363K/year	33%

Regulatory Compliance

• FDA inspection: Zero observations
• ISO Class 5 certification: Maintained
• Customer audits: Zero findings

Explore Our Protective Apparel Solutions

Ready to optimize your cleanroom PPE program? Learn more about our offerings:

• Protective Suits - Tyvek®, Tychem®, and cleanroom apparel
• Packaging Materials - Cleanroom-compatible packaging supplies
• Industrial Labels - Labels for cleanroom and controlled environments

Conclusion

Cleanroom protective apparel programs require precise specification, rigorous procedures, and continuous oversight. By implementing a comprehensive approach, this pharmaceutical manufacturer achieved zero contamination incidents while reducing costs through optimization.

Contact Country Innovation & Supply for a cleanroom PPE assessment.