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Marya Turnkey Cleanroom Solutions for GMP and FDA Compliance1
Air Clean Equipment, Air Shower, Turnkey Cleanroom Solutions, GMP Compliance Cleanroom
Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
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Product Description Marya Turnkey Cleanroom Solutions for GMP and FDA Compliance Product Description Marya delivers end-to-end cleanroom solutions engineered to meet stringent GMP and FDA 21 CFR Part 11/210/211 regulations for life sciences and pharmaceutical industries. Our turnkey systems feature validated HVAC with ±0.5°C temperature control, ISO 5-8 classified zones, and data integrity-ready monitoring for full audit trails. Pre-installed with particle counters, differential pressure alarms, and antimicrobial surfaces, we ensure ready-to-operate compliance from day one. Modular construction allows future expansions without production disruption, while our IQ/OQ/PQ documentation packages accelerate regulatory approvals. Trust Marya for contamination-controlled environments where every detail-from material traceability to air change rates-is pre-validated for uncompromised quality assurance. Features1.Modular design, compact structure2.Full stainless steel SUS3043.Photoelectric control, automatic blowing and showering4.The ventilation circulation design adopts HEPA filtered air to ensure the cleanliness of the mist area in the non-blowing state5.Equipped with airtight sealing box and electromagnetic interlock doors6. The control system adopts a programmable PLC, allowing for arbitrary setting of time, period and spray time. Two modes of automatic control and manual control are available.7.Optional anti-static deviceProduct ParameterFiltration efficiency ≥99.99%@0.5 μm (sodium flame method)Air shower time(s)1~99 seconds adjustable (default 20s)Mist shower time(s)1~99 seconds adjustable (default 20s)Mist particle size10~50 μmSpray nozzle air speed≥20m/sMist shower nozzle number6Air shower nozzle number6Overall dimensions1150W*1000D*2100HAir shower area800W*900D*1950HPower(W)3N 380V 50HzMax power consumption1KWHEPA filter size610*610*70*1pcThe above data is for reference only. In case of ang changes in specification or you need the latest data, please contact us. About UsWorkshopCertificateProject caseOur CustomerExhibition & Our TeamPackaging & Shipping
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