Power Cleaner PS-25 Cleanroom Vacuum System

Overview

The Power Cleaner PS-25 is a purpose-engineered cleanroom vacuum system designed for continuous, contamination-controlled particulate removal in regulated manufacturing and research environments. Unlike general-purpose industrial vacuums, the PS-25 operates on a sealed, negative-pressure suction principle with dual-stage filtration—pre-filter + certified HEPA H13 (EN 1822-1)—to ensure retention of ≥99.97% of airborne particles ≥0.3 µm. Its airflow dynamics are optimized for laminar compatibility: minimal turbulence generation, no recirculation of exhaust air into the cleanroom, and zero particle shedding from housing or internal components. The unit complies with IEST-RP-CC034.3 guidelines for cleanroom-compatible equipment and supports validation protocols required under ISO 14644-1 (airborne particle concentration), USP (pharmaceutical compounding), and EU GMP Annex 1 (aseptic processing). It is not a particle counter or real-time monitor; rather, it functions as an active engineering control to reduce surface and airborne bioburden accumulation during routine cleaning cycles.

Key Features

• Stainless steel (AISI 304) chassis and hose assembly—resistant to 5% nitric acid, 10% sodium hydroxide, and IPA-based disinfectants per ASTM A967 passivation testing
• HEPA H13 filter certified to EN 1822-1 with integrity test port and pre-filter bypass protection to extend service life
• Low-noise brushless motor (≤62 dB[A] at 1 m) engineered for sustained operation without disrupting acoustic-sensitive processes
• Modular filter housing with tool-free access and visual filter saturation indicator
• Grounded static-dissipative hose (10⁶–10⁹ Ω/sq surface resistivity) compliant with ANSI/ESD S20.20
• Integrated vacuum pressure and airflow monitoring via analog gauge—no software dependency for basic operational verification

Sample Compatibility & Compliance

The PS-25 is validated for use on non-porous surfaces common in ISO Class 5–8 environments: epoxy-coated floors, stainless steel workbenches, laminar flow hood interiors, photomask storage cabinets, and semiconductor wafer handling carts. It does not support wet pickup, solvent-laden debris, or pyrophoric residues. All materials contacting process areas meet USP Class VI biocompatibility requirements. Documentation includes Factory Acceptance Test (FAT) report, filter certification (TUV SUD), and material traceability for all wetted parts. The system is compatible with cleanroom gowning protocols—no external plastic housings or painted surfaces that generate lint or outgas VOCs.

Software & Data Management

The PS-25 is a standalone mechanical system with no embedded firmware, network interface, or data logging capability—intentionally designed to eliminate cybersecurity risks, software validation burdens, and electronic failure modes in GMP settings. Maintenance records (filter replacement dates, pressure drop logs, leak checks) are retained manually per site-specific SOPs aligned with FDA 21 CFR Part 211 and EU GMP Chapter 3. Optional calibration services include differential pressure verification against NIST-traceable manometers and filter integrity testing per ISO 14644-3 Annex B.

Applications

• Routine decontamination of ISO 5–7 classified filling lines prior to batch execution
• Removal of photoresist residue and metal sputter dust from lithography tool enclosures
• Cleaning of biosafety cabinet interiors after cytotoxic compound handling
• Pre-operational vacuum sweep of cleanroom walls and ceiling grids to minimize particle resuspension
• Supporting environmental monitoring programs by reducing background particle load before viable/non-viable sampling

FAQ

Does the PS-25 comply with EU GMP Annex 1 requirements for aseptic processing?
Yes—the unit meets the “cleanroom-compatible equipment” criteria in Section 4.37 and supports risk-based contamination control strategies outlined in Annex 1 Rev. 2022.
Can the HEPA filter be sterilized in-place (SIP) or autoclaved?
No—HEPA filters are single-use consumables; steam sterilization would compromise fiber integrity. Replacement intervals are determined by pressure differential monitoring per site SOP.
Is the PS-25 suitable for use in nitrogen-purged gloveboxes?
Not without modification—the standard model draws ambient air; inert-atmosphere variants require custom sealed inlet/outlet manifolds and explosion-proof motor certification.
What is the recommended maintenance frequency for the pre-filter?
Daily visual inspection and weekly dry-brush cleaning; replacement every 50 operating hours or when pressure drop exceeds 1.2 kPa.
Does AS ONE provide IQ/OQ documentation templates?
Yes—validated installation and operational qualification protocols aligned with ASTM E2500 and ISPE GAMP 5 are available upon request with purchase.