Sterile Cleanroom Wipes - Gamma Irradiated, Low-Lint Polyester/Cellulose, ISO 5 Certified

Premium Sterile Cleanroom Wipes for Critical Controlled Environments

Maintain the highest standards of contamination control and surface cleanliness with these professional-grade sterile cleanroom wipes, engineered specifically for critical controlled environments requiring exceptional cleanliness, minimal particulate generation, and validated sterility assurance. These advanced wipers are ideal for pharmaceutical manufacturing cleanrooms, biotechnology laboratories, semiconductor fabrication facilities, medical device production, aseptic processing areas, compounding pharmacies, research laboratories, and any ISO-classified cleanroom environment where contamination control is paramount to product quality, process integrity, and regulatory compliance.

Validated Gamma Irradiation Sterilization

Each cleanroom wipe undergoes rigorous gamma irradiation sterilization processing to achieve a 10⁻⁶ Sterility Assurance Level (SAL), representing the pharmaceutical industry's gold standard for sterility validation. This exceptional SAL of 10⁻⁶ means there is less than one-in-one-million probability of a viable microorganism remaining on the wipe after sterilization, providing the highest level of confidence in sterility for critical applications. Gamma irradiation sterilization offers distinct advantages over alternative sterilization methods including deep penetration throughout the entire wipe material, no chemical residues that could contaminate sensitive processes or products, no heat exposure that could degrade material properties, and validation through established, well-documented protocols recognized by regulatory agencies worldwide. This validated sterility makes these wipes suitable for the most demanding aseptic processing applications, sterile compounding procedures, and critical surface cleaning tasks in Grade A/B cleanroom environments where absolute sterility is non-negotiable.

Extremely Low-Linting Advanced Material Construction

Manufactured from a precisely engineered 68 grams per square meter blend of 55% polyester and 45% cellulose fibers, these cleanroom wipes deliver extremely low particulate generation characteristics essential for maintaining cleanroom classification standards and preventing product contamination. The polyester component provides exceptional durability, chemical resistance, and dimensional stability that prevents the wipe from breaking down or shedding fibers during use, while the cellulose component contributes superior absorbency and effective cleaning performance across diverse surface types and contamination scenarios. This optimized fiber blend is specifically formulated to minimize lint generation and particle release, ensuring that the cleaning process itself does not introduce contamination into the controlled environment. The low-linting properties are critical for applications involving sensitive optical surfaces, precision instruments, electronic components, sterile product contact surfaces, and any scenario where particulate contamination could compromise product quality, process yields, or regulatory compliance.

ISO 5 Cleanroom Environment Certification

These cleanroom wipers are rigorously tested and certified as appropriate for use in critical areas up to and including ISO 5 cleanroom classifications (formerly Class 100), representing some of the most stringent controlled environment standards in pharmaceutical, biotechnology, and semiconductor industries. ISO 5 cleanrooms permit a maximum of 3,520 particles (0.5 microns and larger) per cubic meter of air, requiring all materials, equipment, and supplies used within these spaces to meet exceptionally strict particulate generation limits. The certification of these wipes for ISO 5 environments provides assurance that they will not compromise cleanroom classification through excessive particle shedding, enabling their use in aseptic filling operations, sterile product manufacturing, critical assembly processes, and other applications where maintaining the highest levels of environmental cleanliness is essential for product safety, efficacy, and regulatory approval. This certification also means these wipes exceed the requirements for less stringent cleanroom classifications (ISO 6, 7, 8), making them a versatile choice for facilities operating multiple cleanroom grades.

Maximum Absorbency for Effective Cleaning

With a maximum absorbency capacity of 20-25 milliliters per wipe, these cleanroom wipers deliver exceptional fluid uptake and retention capabilities that enable effective cleaning, disinfection, and spill management in controlled environments. This substantial absorbency allows each wipe to effectively capture and hold cleaning solutions, disinfectants, sterile water, isopropyl alcohol, and other liquids used in cleanroom surface preparation and maintenance protocols. The high absorbency translates to more efficient cleaning operations requiring fewer wipes per task, reduced waste generation, lower overall supply costs, and decreased frequency of wipe changes during extended cleaning procedures. The material's ability to retain absorbed fluids without dripping or releasing liquid back onto cleaned surfaces ensures controlled application of cleaning agents and prevents cross-contamination between cleaned and uncleaned areas. This absorbency performance is particularly valuable for applications involving spill cleanup, surface disinfection with liquid sanitizers, removal of residues or particulates, and preparation of surfaces for sterile operations.

Versatile Critical Environment Applications

These sterile cleanroom wipes support a comprehensive range of critical cleaning and surface preparation applications across diverse controlled environment scenarios. Ideal for cleaning and disinfecting work surfaces, equipment, instruments, and tools in aseptic processing areas; wiping down isolators, laminar flow hoods, and biological safety cabinets; preparing surfaces for sterile operations; cleaning critical product contact surfaces; removing particulates from sensitive equipment; applying disinfectants and sanitizers in validated cleaning protocols; spill cleanup in sterile areas; and general housekeeping in classified cleanroom spaces. The combination of validated sterility, low particulate generation, and high absorbency makes these wipes suitable for both routine maintenance cleaning and critical pre-operational surface preparation in pharmaceutical manufacturing, biotechnology research and production, medical device assembly, semiconductor fabrication, aerospace component manufacturing, and any industry requiring stringent contamination control.

Quality Manufacturing and Material Specifications

The 68 grams per square meter material weight provides an optimal balance between wipe strength, absorbency, and tactile feedback, creating a substantial yet flexible wiper that resists tearing during use while maintaining the delicate touch required for cleaning sensitive surfaces and precision equipment. The polyester/cellulose blend composition is carefully controlled during manufacturing to ensure consistent performance characteristics across all production lots, supporting reproducible cleaning results and reliable contamination control. The material is compatible with a wide range of cleaning agents, disinfectants, and solvents commonly used in cleanroom environments including isopropyl alcohol, sterile water, quaternary ammonium compounds, hydrogen peroxide solutions, and other validated cleaning and disinfection chemistries.

Regulatory Compliance and Documentation Support

These sterile cleanroom wipes support compliance with stringent regulatory requirements including FDA cGMP (current Good Manufacturing Practice) regulations for pharmaceutical and medical device manufacturing, EU GMP Annex 1 guidelines for sterile medicinal products, ISO 14644 cleanroom standards, and USP <797> and <800> requirements for pharmaceutical compounding. The gamma irradiation sterilization process and 10⁻⁶ SAL validation provide the documentation and assurance required for regulatory inspections, quality audits, and validation protocols. Facilities can incorporate these wipes into validated cleaning procedures with confidence that they meet the material specifications and sterility requirements demanded by regulatory agencies and quality management systems.

Product Specifications

• Sterilization Method: Gamma irradiation
• Sterility Assurance Level: 10⁻⁶ (SAL)
• Material Composition: 55% polyester / 45% cellulose blend
• Material Weight: 68 grams per square meter
• Lint Generation: Extremely low-linting construction
• Cleanroom Classification: Suitable for ISO 5 and lower classifications
• Maximum Absorbency: 20-25 milliliters per wipe
• Applications: Critical area cleaning, surface disinfection, spill cleanup
• Industries: Pharmaceutical, biotechnology, medical device, semiconductor, aerospace
• Regulatory Support: cGMP, EU GMP, ISO 14644, USP compliant
• Chemical Compatibility: Compatible with common cleanroom disinfectants and solvents

These sterile cleanroom wipes represent an essential component of contamination control supply inventories for facilities operating critical controlled environments where product quality, patient safety, and regulatory compliance depend on maintaining the highest standards of cleanliness and sterility. The combination of validated gamma irradiation sterilization, extremely low-linting material construction, ISO 5 cleanroom certification, and exceptional absorbency makes these wipes a trusted choice for pharmaceutical manufacturers, biotechnology companies, medical device producers, and any organization committed to excellence in contamination control and cleanroom operations.