Floors collect and concentrate particulate and microbial contamination. Every step can re-suspend particles, transport contamination across boundaries, and transfer residues into higher-grade zones. Sterile boot covers help reduce what footwear brings into the cleanroom — but only when gowning technique prevents ties, cuffs, and boot material from contacting the dirty side or the floor during donning.

• Material: 100% polypropylene breathable SMS (barrier + comfort positioning).
• Sterilization: gamma irradiation with stated SAL 10^-6.
• Packaging: triple bagged and vacuum packaged; sterility indicator included (manufacturer stated).
• Footwear design: vinyl sole / vinyl trimmed edge and grasp ties attached at the foot for better fit (manufacturer stated).
• Restrictions statement: no natural rubber latex, no silicone, no BHT preservative (manufacturer stated).

Practical control point: treat the boot cover as a “floor-contact garment.” If ties drag, cuffs brush the dirty side, or boots are donned while standing on contaminated flooring, the barrier is compromised before you enter the critical area. In most facilities, the cleanroom bench (dirty side / clean side) is the physical control that makes sterile footwear donning repeatable across shifts.

ISO baseline: ISO cleanroom classification is defined by airborne particle concentration. Your cleanroom “class” is only credible if operations control reduces contamination generation and transfer from personnel and materials.

• ISO 14644-1 provides the classification framework (particle-based) used across industries for cleanrooms and controlled environments.
• ISO 14644-5 specifies operations control program expectations, including management of personnel, entry/exit of personnel and materials, cleaning, maintenance, and monitoring.
• Footwear control (boots + disciplined donning) is a practical “personnel operations” measure that supports cleanliness levels by reducing floor-borne transfer and gowning variability.

EU GMP Annex 1 (sterile manufacturing add-on): Annex 1 raises the bar for sterile medicinal products by emphasizing contamination control through quality risk management, facility/equipment controls, and disciplined personnel practices. For aseptic processing, gowning systems — including sterile footwear and validated gowning steps — are treated as essential controls to reduce both microbial and particulate contamination risk.

Use this checklist to align incoming product with your SOP, cleanroom grade, and documentation expectations. When a program requires it, tie each case to lot/certificate records in your quality system.

Attribute	Manufacturer-stated basis
Sterility	Gamma irradiated; SAL 10-6; sterility indicator included
Packaging format	Triple bagged; vacuum packaged; individually packed pairs (case-level presentation varies by sheet)
Material	100% polypropylene breathable SMS
Cleanroom suitability	Suitable for ISO Class 5 or higher cleanrooms
Footwear design	Vinyl sole / vinyl trimmed edge; grasp ties attached at foot; serged seams
Case quantity	100 pairs/case; size codes include 31683 (SM/MD), 31696 (Universal), 31697 (XL/2XL)
Certificates	Certificate of Conformance and Certificate of Irradiation referenced as available online (manufacturer portal)
Expiration dating	Expiration date stated as 5 years from manufacture

• Ties contact the floor: hold ties up and away from the dirty side; use the cleanroom bench method.
• Standing donning on dirty flooring: convert to seated/bench donning with a clear dirty/clean split.
• Loose fit / drag: choose correct size and tie placement; ensure the boot is secured above the ankle and positioned over the shoe/boot front before tying.
• Package breach ignored: inspect vacuum seal and sterility indicator before entry; reject compromised packs per SOP.

• Choose Grasp Ties when your gowning program prioritizes aseptic donning control and secure fit with less handling variability.
• Confirm size (SM/MD, Universal, XL/2XL) to reduce trip/drag hazards and improve seal at the ankle/calf.
• Wet areas: manufacturer materials reference vinyl sole / trimmed edge designs intended to reduce slip and liquid penetration risk (qualification is site-specific).