FULL COMPLIANCE USP 795, 797, 800 - cGMP Our team consists of FDA Pharmaceutical Process Consultants, From Design To Compound Pharmacists, Architects, and Engineers. All our material suppliers are trusted manufacturers in the cleanroom space VALIDATION providing the latest most efficient products and accountability. Our Cleanroom Promise Whether you have a 200-sq. ft. or a 20.000-sq. ft. facility, our team will customize the project in accordance to your budget & compliance requirements. We are focused on providing you a cost effective solution for your cleanroom project in a timely manor. Sterile Lab Design commitment to TCG members Our team will work at all aspects of your buildout; beyond quality and aesthetics. We will work with your builder. HVAC, and electrical contractors to make sure every detail is covered from an initial budget perspective to planning for final validation. Free Consulting: We will be available at no cost to discuss your needs, questions, and/or concerns regarding current legislation and your compounding level. Free CAD: We will provide an exact design for your cleanroom layout at no cost. This is a must work flow consideration. We work directly with U.S. based manufacturers to provide best pricing and design options. We know we can earn your business. STRESS-FREE FULL-SERVICE FULL COMPLIANCE CONCIERGE CUSTOMIZATION ISO-Class V, VII and VIII USP & FDA Consultancy Variety of compliant Wall Systems FDA C.F.R. 211 Architecture Design and Setup Aseptic Workflow Optimization FDA C.F.R. 111 Cleanroom Engineering Long-lasting Aluminum Stud System cGMP S.O.P. Audit and Validation Panel Design Customization USP 800 Install and Prep HEPA Filtration Customization USP 797 Cleanroom ISO Validation Finest Environment Control Expand-Ready Hassle-Free Modular INQUIRE ABOUT A Interested in learning more? Contact: FREE Paul Murphy, Vice President [email protected] INITIAL CONSULT (888) 663-1555
www.sterilelabdesign.com 400 Series Class I Biological Safety Cabinet Series Model Number The 400 series has a Class I powder containment hood for 40043 non-sterile Hazardous compounding. Class:I LCD Display Class Approved Use Large digital display is easy to monitor all the safety parameters at a glance and USP 800 non-sterile Guidance ergonomically sized control panel improves user interface. HazMat Drug Handling Work Zone Quality Validation One-Year Product Warranty Work zone, made of 304 stainless steel is surrounded by negative pressure. ISO-Class 1-5 Validation Documentation Remote Control NQA Global Assurance Conformity All functions can be realized with it, making the operation much easier and more ISO 9001 Registered convenient. ISO 14001 Registered CE Certified UV Lamp Emission of 253.7 nanometers for most efficient decontamination. Front Window Two-layer laminated toughened glass > 5mm, anti UV Footmaster Caster Universal caster with brake and leveling feet. ADVANTAGES 1. UV lamp for sterilization. 2. Soft touch control panel, LCD display. 3. Energy-saving, high efficiency, low noise. 4. With memory function in case of power-failure. 5. One piece 304 stainless steel work stable, easy for cleaning. 6. Stable air flow system; provide firm protection to person and environment.
Class I Biological Safety Cabinet (400 Series – TECHNICAL PARAMETERS) Model BYKG-V External 43*27*76 in Size(W*D*H) Internal 38*27*24 in Size(W*D*H) Airflow Velocity 0.75~1.0m/s Main Body Cold-rolled steel with anti-bacteria powder coating Construction Work Table 304 stainless steel HEPA Filter 99.999% efficiency at 0 .3µm Noise ≤67dB Fluorescent Lamp 21W*1 20W*1 UV Lamp Emission of 253.7 nanometers for most efficient decontamination BYKG-III has UV timer function and the display could indicate the UV life. Consumption ≤350W Caster Universal caster Power Supply AC220V±10%; 50/60Hz: 110V±10%, 60Hz Standard Accessory Fluorescent lamp. UV lamp*2.Base stand. Optional Accessory Electronic height adjustable base stand Gross Weight 185kg Package 50*34*87 in Size(W*D*H)
www.sterilelabdesign.com 500 Series Horizontal Laminar Flow Cabinet Series Model Number The Horizontal 500 series is a carefully enclosed 50051/50071 compounding bench designed to protect sterile products within work zone from particulates. It is Internal Dimensions required for use with non-hazardous sterile 41 x 20 x 26 in compounding. 57 x 20 x 26 in LCD Display External Dimensions 51 x 32 x 67 in Large digital display is easy to monitor all the safety parameters at a glance 71 x 32 x 67 in and ergonomically sized control panel improves user interface. Class Approved Use Work Zone Sterile Compounding USP 797 Guidance Work zone, made of 304 stainless steel is surrounded by negative pressure. Quality Validation Remote Control One-Year Product Warranty All functions can be adjusted with it, making the operation much easier and ISO-Class 1-5 Validation more convenient. Documentation NQA Global Assurance UV Lamp Conformity ISO 9001 Registered Emission of 253.7 nanometers for most efficient decontamination. ISO 14001 Registered CE Certified Front Window Two-layer laminated toughened glass > 5mm, anti UV Footmaster Caster Universal caster with brake and leveling feet. Foot Switch Adjust front window height by foot during experiment, to avoid airflow turbulence caused by arm movement.
Horizontal Laminar Flow Cabinet (500 SERIES – TECHNICAL PARAMETERS) Model 50051 50071 External 51 x 32 x 67 in 71 x 32 x 67 in Size(W*D*H) Internal 47 x 20 x 25 in 67 x 20 x 25 in Size(W*D*H) Work Surface Height 29.53in Display LED Display Airflow Velocity Material Average of 0.3- 0 .Sm/s Pre-filter Main Body: Cold-rolled steel with anti-bacteria powder coating HEPA Filter Noise Work Table: 304 stainless steel Fluorescent Lamp UV Lamp Side Windows: 5mm toughened glass. anti-UV Consumption Polyester fiber. washable Waterproof socket Caster 99.999% efficiency at 0 .3um Power Supply Standard Accessory <60dB Gross Weight 21W*1 28W*1 Package Size(W*D*H) 20W*1 30W*1 Emission of 253.7 nanometers 320W 620W Two. Total load ≤ 500W Universal caster with leveling feet AC220V±10%; S0/60Hz: 110V±10%, 60Hz Fluorescent lamp. UV lamp*2.Base stand. Waterproof socket*2 179kg 179kg 48.42*39.37*71.65 in 64.17*39.37*71.65 in
www.sterilelabdesign.com 500 Series Vertical Laminar Flow Cabinet Series Model Number The Vertical 500 series is a carefully enclosed V50051/V50071 compounding bench designed to protect sterile products within work zone from particulates. It is required for use with non-hazardous sterile compounding. Internal Dimensions LCD Display 41 x 20 x 26 in 57 x 20 x 26 in Large digital display is easy to monitor all the safety parameters at a glance and ergonomically sized control panel improves user interface. External Dimensions Work Zone 51 x 30 x 80 in 71 x 30 x 80 in Work zone, made of 304 stainless steel is surrounded by negative pressure. Class Approved Use Remote Control Sterile Compounding USP 797 Guidance All functions can be adjusted with it, making the operation much easier and more convenient. UV Lamp Emission of 253.7 nanometers for most efficient decontamination. Quality Validation Front Window One-Year Product Warranty ISO-Class 1-5 Validation Two-layer laminated toughened glass > 5mm, anti UV Documentation NQA Global Assurance Footmaster Caster Conformity ISO 9001 Registered Universal caster with brake and leveling feet. ISO 14001 Registered CE Certified Foot Switch Adjust front window height by foot during experiment, to avoid airflow turbulence caused by arm movement.
Vertical Laminar Flow Cabinet (500 SERIES – TECHNICAL PARAMETERS) Model V50051 V50071 External 51 x 30 x 80 in 71 x 30 x 80 in Size(W*D*H) Internal 47 x 20 x 25 in 67 x 20 x 25 in Size(W*D*H) Work Surface Height 29.53in Display LED Display Airflow Velocity Material Average of 0.3- 0 .Sm/s Pre-filter Main Body: Cold-rolled steel with anti-bacteria powder coating HEPA Filter Noise Work Table: 304 stainless steel Fluorescent Lamp UV Lamp Side Windows: 5mm toughened glass. anti-UV Consumption Polyester fiber. washable Waterproof socket Caster 99.999% efficiency at 0 .3um Power Supply Standard Accessory <60dB Gross Weight 21W*1 28W*1 Package Size(W*D*H) 20W*1 30W*1 Emission of 253.7 nanometers 320W 620W Two. Total load ≤ 500W Universal caster with leveling feet AC220V±10%; S0/60Hz: 110V±10%, 60Hz Fluorescent lamp. UV lamp*2.Base stand. Waterproof socket*2 179kg 179kg 48.42*39.37*71.65 in 64.17*39.37*71.65 in
www.sterilelabdesign.com 600 Series NSF Certified BioSafety Cabinet Series Model Number The 600 series provide a completely 60043/60054/60074 enclosed, well ventilated work area specifically built to protect laboratory Class:2 A2 personnel when working with hazardous materials. Internal Dimensions 36 x 24 x 26 in LCD Display 45 x 24 x 26 in 54 x 24 x 26 in Large digital display is easy to monitor all the safety parameters at a glance and ergonomically sized control panel improves user interface. External Dimensions 43 x 31 x 90 in Work Zone 54 x 31 x 90 in 74 x 31 x 90 in Work zone, made of 304 stainless steel, is surrounded by negative pressure. Class Approved Use Remote Control Sterile Compounding Hazmat Handling All functions can be realized with it, making the operation much easier and USP 800 Guidance more convenient. USP 797 Guidance UV Lamp Quality Validation One-Year Product Emission of 253.7 nanometers for most efficient decontamination. Warranty ISO-Class 1-5 Validation Front Window Documentation NQA Global Assurance Two-layer laminated toughened glass > 0.2 in. anti UV Conformity ISO 9001 Registered Footmaster Caster ISO 14001 Registered CE Certified Universal caster with brake and leveling feet. Foot Switch Adjust front window height by foot during experiment, to avoid airflow turbulence caused by arm movement.
NSF Certified BioSafety Cabinet (600 SERIES – TECHNICAL PARAMETERS) Model 60043 60054 60074 External Size(W*D*H) 43 x 31 x 90 in 54 x 31 x 90 in 74 x 30 x 90 in Internal Size(W*D*H) 36 x 24 x 26 in 45 x 24 x 26 in 53 x 24 x 26 in Work Surface Height 29.5 in Max Opening 550mm (22\") Tested Opening Safety height 200mm (8\") Airflow Inflow 349m3/h(205cfm) 465m3/h(275cfm) 649m3/h(382cfm) Velocity Down flow 64%:638m3/h (375cfm) 64%:868m3/h (498cfm) 64%:1190m3/h (700cfm) Exhaust 36%:359m3/h(211 cfm) 36%:488m3/h (287cfm) 36%:669m3/h(394cfm) Front Window Motorized. Two-layer laminated toughened glass ≥5mm. Anti UV HEPA Filter Two. 99.999% efficiency at 0 .3µm filter life indicator Filter Guard Type Aluminum alloy frame Noise NSF 49≤561 dB/EN 12469≤558 dB Illumination ≥ l,000 Lux Display LCD Display Waterproof socket Two. Total consumption: ≤ 500W Tap Water tap*l. Gas tap *1 Ground Resistance ≤ 0.10 Ω Power Supply AC220/110V±l0%. 50/60Hz ±1Hz. Full load Amps: 9A. BTU/Hr: 1689 Consumption 300W 400W 500W Alarm Abnormal airflow velocity: Filter change: Front Window over height Motor One ECM motor. llOV& 220V acceptable. Speed adjustable. high efficiency and low power consumption Material Working area: 304 stainless steel/ Frame and Decorative Plate: cold-rolled steel with anti-bacteria power coating UV Lamp 18W 30W 40W Germicidal UV lamp, Emission of 253.7 nanometers for most efficient decontamination Standard Fluorescent lamp, UV lamp *2, Base stand, SS water & gas taps, Drain valve. Accessory Waterproof sockets, Stainless Steel l.V. Bar with 10 hooks Optional Armrest. Airflow tester. Formalin fumigation sterilizer, infrared sterilizer. Accessory Adjustable base stand. Remote control Package Size (W*D*H) 49*42.5*72 in 60.6*42.5*75 in 80*42.5*75 in Gross 595.21b 736.3 800.3 Weight
www.sterilelabdesign.com 800 Series Biological Safety Cabinet Series Model Number The 800 series has a higher class of safety 80043/80051/80059/80072 protection compared with type A2, it may be used for work with USP 800 Hazardous sterile compounding. Class: LCD Display 2-82 Large digital display is easy to monitor all the safety parameters at a glance and Internal Dimensions ergonomically sized control panel improves user interface. 37 x 24 x 26 in 45 x 24 x 26 in Work Zone 53 x 24 x 26 in 66 x 24 x 26 in Work zone, made of 304 stainless steel, is surrounded by negative pressure. External Dimensions Remote Control 43 x 30 x 89 in 51 x 30 x 89 in All functions can be realized with it, making the operation much easier and more 59 x 30 x 89 in convenient. 72 x 30 x 89 in UV Lamp Class Approved Use Sterile Compounding Emission of 253.7 nanometers for most efficient decontamination. Hazmat Handling USP 800 Guidance Front Window Two-layer laminated toughened glass > 5mm. anti UV. Footmaster Caster Universal caster with brake and leveling feet. Quality Validation Foot Switch One-Year Product Warranty ISO-Class 1-5 Validation Adjust front window height by foot during experiment, to avoid airflow turbulence Documentation caused by arm movement. NQA Global Asurance Conformity Waterproof Socket ISO 9001 Registered ISO 14001 Registered 2 waterproof sockets are located in the side wall, for optimum convenience of using CE Certified small devices inside the cabinet. Exhaust Blower Centrifugal fan, speed adjustable.
Biological Safety Cabinet (800 SERIES – TECHNICAL PARAMETERS) Model 80043 80051 80059 80072 External Size(W*D*H) 37 x 24 x 26 in 45 x 24 x 26 in 53 x 24 x 26 in 66 x 24 x 26 in Internal Size(W*D*H) 43 x 30 x 89 in 51 x 30 x 89 in 59 x 30 x 89 in 72 x 30 x 89 in Tested Opening Safety Height ≤ 200 mm (8\") Max Opening 420 mm (17\") 420 mm (17\") 500mm (20\") 500mm (20\") Inflow Velocity 0.53±0.025 m/s Downflow Velocity 0.33±0.025 m/s Pre-Filter Washable HEPA Filter Two. 99.999% efficient at 0.3 um. Filter life indicator. Front Window Motorized. Two-layer laminated toughened glass ≥ 5mm. Anti UV. Noise NSF49≤561dB I EN12469≤558 dB UV Lamp 30Wx 1 18Wx 1 40Wx 1 40Wx 1 UV timer. UV life indicator, emission of253.7 nanometers for most efficient decontamination. Fluorescent Lamp 21Wx 2 21Wx 2 28Wx2 40Wx2 Illumination ≥1000Lux Consumption 700W 850W 900W 1200W Waterproof Sockets Two. total load of two sockets: 500W Display LCD display: exhaust filter and downflow filter pressure, filter and UV lamp working time, inflow and downflow velocity, filter life, humidity and temperature. system working time etc. Control System Microprocessor Airflow System 0% air re-circulation. 100% air exhaust Visual and Audio Alarm Filter replacement, window over height, abnormal air flow velocity. Exhaust Duct 4 meters PVC duct. Diameter:300mm Material Work Zone: 304 stainless steel Main Body: Cold-rolled steel with anti-bacteria powder coating. Work Surface Height 29.5 in Caster Footmaster caster Power Supply 110/220V±10%, 60/50Hz (110V/60Hz is not applicable to BSC-180011B2-X) Standard Accessory Standard Accessory Fluorescent lamp, UV lamp*2, base stand, remote control, foot switch, exhaust blower, exhaust duct, drain valve, waterproof sockets*2, pipe strap*2. Optional Accessory Water and gas tap Gross Weight 246kg 302kg Package 48*39.4*72.4 in 57.1*41.3*70.9 in 65*39*70.9 in 65*939*76.8 in Main Body (W*D*H) Package 38.2*31.9*24.8 in 38.2*31.9*24.8 in 38.2*31.9*24.8 in 38.2*31.9*24.8 in Exhaust Blower (W*D*H)
www.sterilelabdesign.com 900 Series Cytotoxic Safety Cabinet Series Model Number Cytotoxic Safety Cabinet is the premium ENGCSC-90016-C02-C01 solution for cytotoxic I antineoplastic Drug compounding, providing the highest level of Class:2-C1 patient, pharmacist, and environmental protection. Internal Dimensions 36 x 24 x 25 in LCD Display 48 x 24 x 25 in Large digital display is easy to monitor all the safety parameters at a glance External Dimensions and ergonomically sized control panel improves user interface. 43 x 30 x 82 in Work Zone 54 x 30 x 82 in Work zone, made of 304 stainless steel is surrounded by negative pressure. Class Approved Use Sterile Compounding Remote Control Chemotherapeutic Compounding All functions can be realized with it, making the operation much easier and Antineoplastic Compounding more convenient. Hazmat Handling USP 800 Guidance UV Lamp USP 797 Guidance USP 795 Guidance Emission of 253.7 nanometers for most efficient decontamination. Quality Validation Front Window One-Year Product Warranty ISO-Class 1-5 Validation Two-layer laminated toughened glass > 5mm, anti UV Documentation NQA Global Assurance Footmaster Caster Conformity ISO 9001 Registered Universal caster with brake and leveling feet. ISO 14001 Registered CE Certified Foot Switch Adjust front window height by foot during experiment, to avoid airflow turbulence caused by arm movement. Waterproof Socket 2 waterproof sockets are located in the side wall, for optimum convenience of using small devices inside the cabinet. Exhaust Blower Centrifugal fan, speed adjustable.
Cvtotoxic Safety Cabinet (900 SERIES – TECHNICAL PARAMETERS) Model 90043 Internal size(W*D*H) 48 x 24 x 25 in External size(W*D*H) 54 x 30 x 82 in Tested Opening Working Opening 440 mm (17') Internal Work Area, space 0.73 m3 Inflow Velocity 0.53 m/s Down Flow Velocity 0.33 m/s Exhaust Volume 465 m3/h (237 cfm) Air Supply Filter Exhaust Filter ULPA filter. Efficiency > 99.999% for partical size at 0.12 µm 2 pieces HEPA filters, efficiency > 99.999% for particle at 0.3 µm. Filter life Alarm indicator and filter working time indicator. Audio and visual alarm .filter replacement .window over height abnormal Noise airflow velocity. Water & Gas Tap EN12469≤58dB/NSF49≤61 dB UV lamp Water Tap*1. Gas tap*l Fluorescent Lamp 30 W*1 - Emission of 253.7 nanometers for most efficient decontamination UV Illumination life indicator Consumption 28W*2 Waterproof Socket ≥1000 lux Display Control System 900W Humidity and Temperature Two ; total load of two sokets :≤500W Material LCD Display Microprocessor Front Window Humidity and temperature can be displayed on the control panel. Caster Work Area: 304 stainless steel; Power Supply Main Body: Cold-rolled steel with anti-bacteria powder coating Standard Configuration Moterized, two-layer laminated 5mm toughened glass. Anti UV. Footmaster Caster Optional accessory AC220V± 10%,50/60HZ 110V±l0% 60HZ Base stand. Drain valve, waterproof sockets*2, Remote control, UV lamp*2 and Gross weight Fluorescent Lamp, Water tap, Gas tap. Package Size(W*D*H) Armrest. Formalin fumigation sterilizer, infrared sterilizer, Airflow tester, PVC duct. 7721bs 61*35*90 in
Air Sterilization Group •• • UV Air Sterilizer Mobile • 00 128 series .z ORJ II.. . ,�. ::•,f,•• , ❖i :l, -..... 'I.· �· %j·.!. :x..- .I;p.,. . . ...:. \": For more information or to order visit www.sterilelabdesignasg.com - Room Air fm Primary Filtered Air c:J HEPA Filtered Air Primary Filter -----------------------------------------------
The Sterile Lab Design aerosol adsorber is an innovative air purification system, designed to help clean the air you breath and protect your health by filtering dust, allergens, bacteria and viruses from the air, removing 99.97% of airborne particles down to 0.3 micrometers. Our system has versatile applications across hospitals, clinics, pharmacies, labs, offices, meeting rooms and home. Key Features 1. Highly effective, UV Lamp sterilization 2. Low noise 3. LCD Display 4. Remote control 5. Adjustable air velocity 6. Mobile unit TECHNICAL PARAMETERS Model 128 series External Size(W*D*H)in. 34.5\"x4.7\"x59\" Filter Primary Filter, HEPA filter Optimal Space S20m2 <2317 sqft Noise S58dB Consumption 240W Adjustable Air Speed 3 levels Power Supply AC220V±10%, 50/60Hz; 11OV±10%, 60Hz Cleanness at Outlet Class 100 Gross Weight 127.6lb Package Size(W*D*H)in 71\"x17.3\"x41.3\" ' I • • -• ---------------------------------Version 2019 057/058
® For more information or to order visit www.sterilelabdesignasg.com Air Sterilization Group UV Air Sterilizer 800 series ,,..................................... The Sterile Lab Design UV Air Sterilizer is an innovative air purification system, designed to help clean the air you breath and protect your health by filtering dust, allergens, bacteria and viruses from the air, removing 99.97% of airborne particles down to 0.3 micrometers. Our system has versatile applications across hospitals, clinics, pharmacies, labs, offices, meeting rooms and home. Features: * Simple operation, with one illuminated switch to turn on and off * Manually controlled disinfection operation * Quick disassembly, convenient for daily cleaning and maintenance. * Air sterilization enabled by unique ozone-free ultraviolet wave technology, antibacterial anti-virus * Silent operation * Innovative air flow system allows unit to be placed against the wall or in tight corners * Easy to move using silent swivel casters Technical Parameters: Model 800 series Circulating Air ::::800m3/h Noise :555dB 03 concentration in the air during dynamic disinfection :50.1mg/m3 Applicable Room Ultraviolet Leakage :580m3 2825 cubic ft :55µw/m2 Temp.Range -10°(-40°( Working Environment Humidity :580% 60KPa-106KPa Atmosphere Pressure :5350W Consumption AC220V±10%, 50/60Hz Power Supply 16.7\"x12\"x32.7\" External Size(W*D*H)in. 20\"x15\"x36.6\" Packing Size(W*D*H)in. 62.7 Gross Weight(lb)
Search
Read the Text Version
- 1 - 16
Pages: