LAF SYSTEMS

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AM INSTRUMENTSLAF SYSTEMSSTANDARD AND CUSTOMIZABLE MODELS

AM Instruments develops, builds and validates laminar airflows for class ISO5 areas (according to ISO 14644-1). The flexibility of the air modules allows AM to shape projects around clients’ true requirements. From standard modules, assembled with different dimensions and layouts, to down-cross booths; from traditional pass throughs and biodecontaminant iHP or nHP technology machines, to air showers, laf cabinets and laf trolleys that without any power supply are developed for safe transfer of materials from grade A areas to grade A areas, passing through lower classified zones.

A team of qualified designers, technicians and operators support the client during all the phases, from development to delivery, including after sales assistance.

Advanced design and technology, adaptive architecture and operating excellence.

Industries: pharmaceutical, chemical, electronic, food processing; production and research.

• Multiplo®

• down-cross booths • material pass throughs • MyBox • air showers • laf trolleys • laf cabinets • AM LAF (customized solutions)

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The standard Multiplo® module is a self-contained unit with HEPA filters and fan built in 4 standard dimensions. The machine can be assembled according to the class ISO5 working area layout (compliant with ISO 14644-1), responding to the needs of sectors that require controlled environments for specific phases of their production process.

The standard module is entirely made of AISI 304 stainless steel with Scotch Brite® finishing.

The module is supplied with:

• HEPA filter EU14 – CEN H14 efficiency 99.995 MPPS (particles 0.12 – 0.24 μm) ≥ 99.999 DOP (0.3 μm) • centrifugal motor fan, grade IP55 protection • plenum made of stainless steel fitted for entry of 100% DOP

The module is built with the following features:

• holes in the structure to connect with other units • holes in the structure to connect to the supporting legs • holes in the structure to connect the ringbolts for ceiling installation • slot for stainless steel panels and pre-filters • holes in the structure for curtain fitting

The modules can be completed with a wide range of accessories, such as:

• supporting legs • PVC curtains • tri-clamp on panel to verify filter efficiency with aerosol generator and photometer • LED lighting • differential pressure gauge • pressure switch • remote/integrated electrical panel

WORKING PRINCIPLE

Air is drawn from the environment by way of side pre-filters, then the motor blower forces the air into the plenum that distributes the pressure evenly on the surface of the HEPA filters, in order to guarantee downstream laminar airflow. The area surrounding the motor blower is kept under negative pressure thus enhancing the intrinsic safety of the Multiplo® system.

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LAF SYSTEMS

MULTIPLO®

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MULTIPLO®

DOCUMENTATION

Multiplo® comes with a digital version operating manual that contains:

• proper use procedure • regular maintenance procedure • report of the functional tests performed during the testing phase at our facility • CE certificate of conformity • original certificates of the HEPA filters and fans

RULES AND REFERENCE GUIDELINES

• CEI EN60204-1 • machinery directive 2006/42/CE • electromagnetic compatibility directive 2004/108/CE • low voltage directive 2006/95/CE (applicable to the electrical panel only)

LAF0010N LAF001N LAF0020N LAF0030N

external dimensions – mm 680x680x610h 1360x680x610h 1360x1360x610h 1360x2040x610h

maximum heighton the support - mm 3000 3000 3000 3000

usable heighton the support - mm 2390 2390 2390 2390

HEPA filter dimensions - mm 610x610x66h 610x1220x66h 610x1220x66h 610x1220x66h

number of HEPA filters 1 1 2 3

number of centrifugal fan motors 1 1 2 3

number of plenums 1 1 2 3

total airflow rate at 0.45 m/secair speed 600 m3/h 1200 m3/h 2400 m3/h 3600 m3/h

class of contamination downstream of the filter ISO5 ISO5 ISO5 ISO5

weight – kg 40 65 120 180

sound level – db(referred to n. 1 module) ≤ 60 ≤ 60 ≤ 63 ≤ 65

electrical protection IP55 IP55 IP55 IP55

power supply 230V-50/60Hz 0.4KW

230V-50/60Hz 0.8KW

230V-50/60Hz 1.6KW

230V-50/60Hz 2.4KW

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LAF SYSTEMS

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DOWN-CROSS

The AM Instruments powder handling down-cross booth is a vertical laminar flow unit designed for solid dosage processes, IBC systems and drum weighing. It guarantees operator exposure levels of < 100 μg/m3 TWA which can be reduced with the use of flexible or rigid barriers to < 10 μg/m3 TWA.

• top quality finishing for the pharmaceutical sector • cGMP compliance • highly efficient fans • AISI 304 stainless steel structure • integrated electrical panel • alarm management • validation • IQ and OQ documentation according to cGMP standards • customized solutions

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TECHINCAL SPECIFICATIONS

The structure is composed of 2 upside-down shape L elements. The vertical block houses the dihedral filters, the thermal exchange batteries (if included) and the motor fan/s; the horizontal block that works as a ceiling for the whole unit houses the air distribution duct, the spiral tubes, the plenums, and the inlet and exhaust HEPA filters.

• stand alone structure made of AISI 304 stainless steel with Scotch Brite® finishing • HEPA filters for inlet air, dismountable from below, efficiency 99.999% on particles size 0.3 μm • frame made of anodized aluminum, protection grid in stainless steel • HEPA filters for exhaust air, efficiency 99.999% on particles size 0.3 μm • n. 1 series of centrifugal motor fans, double intake • pre-filters mm 595 x 595 x 290h, efficiency 95%, F8 according to CEI EN 779, assembled on vertical air duct • PVC curtains on 3 sides, mm 2100h • n. 1 differential pressure gauge connected to the HEPA filter plenum • n. 1 differential pressure gauge connected to filter downstream of the pre-filters • LED light bar IP40 • electrical panel in stainless steel IP54 housed in the booth:

• n. 1 general switch • n. 1 control light • n. 1 LAF functioning control light • n. 1 light switch

• set of ringbolts • n. 2 stainless steel side legs

Customizable dimensions of the entire structure.

DOCUMENTATION

Down-cross booth comes with a digital version operating manual that contains:

• proper use procedure • regular maintenance procedure • report of the functional tests performed during the testing phase at our facility • CE certificate of conformity • original certificates of the HEPA filters and fans

RULES AND REFERENCE GUIDELINES

• CEI EN60204-1 • machinery directive 2006/42/CE • electromagnetic compatibility directive 2004/108/CE • low voltage directive 2006/95/CE (applicable to the electrical panel only)

DOWN-CROSS

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LAF SYSTEMS

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MYBOX

A NEW GENERATION OF BIODECONTAMINATION PASS BOXESWITH HYDROGEN PEROXIDE

AM Instruments, having developed extensive experience in environmental surface biodecontamination using dry fog hydrogen peroxide systems at low concentrations (<8%), has developed a new generation of fully automated pass boxes.The advantages of this technique are a bacterial surface reduction of 6 log, repeatable and validable; very short sterilization cycle and the possibility of sterilizing thermolabile materials, including electronic equipment.MyBox is produced according to current GMP standards for pharmaceutical environments with high quality materials and finishing. The machine is able to execute automatic biodecontamination cycles via integrated PLC, adapting to the technical specifications of each load.During the validation phase, the chemical and microbiological mapping with bio-indicators (Geobacillus Stearothermophilus) ensures the effectiveness and correct distribution of the hydrogen peroxide, proving the cold sterilization of the load. MyBox can be easily installed between two different classified areas/rooms for material pass through and ensures surface sterilization. This device is essential anytime the products/components to be sterilized are not sterilizable in the autoclave.

BENEFITS

• high compatibility with all materials used in controlled environments • simple and comprehensive design • log 6 surface bacterial load reduction • working chamber entirely made of AISI 316 stainless steel with mirror finishing • external structure and supports made of AISI 304 stainless steel with Scotch Brite® finishing. Available upon request also AISI 304 or AISI 316 with mirror finishing • HMI with touch screen • customizable sterilization cycles • HEPA H14 inlet air filtering for class B working chamber, according to cGMP Annex 1 • customizable software and hardware solutions • possibility to set up automatic messages/emails in case of alarms, anomalies, end of cycle • low temperature sterilization, fast, repeatable, reliable and validable • no damage to thermolabile materials • Validation Support Package (HDS, SDS, FS, FAT, SAT, IQ, OQ, PQ)

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MYBOX iHP TECHNOLOGY

• volume of the chamber > 4m3

• iHP integrated generator • sustainable cycle: the residues of hydrogen peroxide are not toxic (water and oxygen)

GENERATORWITH iHP TECHNOLOGY

iHP (ionized hydrogen peroxide) is an integrated solution that offers validated decontamination cycles with a surface bacterial load reduction > 6 log that includes viruses, bacteria, fungi/molds and spores. The system has a control panel that can be connected to a supervising system for a complete automation of the cycle.A liquid solution (< 8% hydrogen peroxide) is forced through a nozzle, creating a mist, which then passes

through a high voltage arc that ionizes the solution for a quick spreading throughout the area, killing all airborne and surface microorganisms on contact. The electrostatic charge, generated by the ionization process causes the hydrogen peroxide mist to act like a gas where the positively charged particles are attracted to the negatively charged surfaces including cracks, crevices and hard-to-reach areas, thereby eliminating the need for circulation fans.

• high compatibility with all materials used in controlled environments • utilities required: compressed air, connection to electrical supply and external exhaust system • simple and comprehensive design

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LAF SYSTEMS

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MYBOX nHP TECHNOLOGY

• volume of the chamber up to 4m3

• nHP integrated generator • sustainable cycle: the residues of hydrogen peroxide are not toxic (water and oxygen)

NEBULIZERWITH nHP TECHNOLOGY

• airbourne surface disinfection is an innovative technique based on the atomization of a disinfectant. The product, in the form of droplets, is spread in the environment. This technology, also called “dry nebulization” allows the disinfection of surfaces, reaching even the less accessible zones, without residues. • patented technology

SPINNING DISC TECHNOLOGY

• the spinning disc, placed on the top of the instrument, is fed with the sanitizing solution, kept inside a tank, by way of a peristaltic pump. • the spinning of the disc, 45.000 rotations per minute, breaks the solution creating a fine fog (5-10 μm).

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TECHNICAL DATA

MYBOX nHP

model-300 model-2000

external dimensions* (LxWxH) 1400x950x 3000 mm 2400x1450x3300 mm

working chamber dimensions* (LxWxH) 700x600x700 mm 1100x1300x1600 mm

working chamber volume 0.3 m3 2 m3

class of contamination ISO5 vertical laminar flow according to ISO 14644-1

duration of sterilization cycle < 100 minutes (full chamber standard load)

inlet air flow rate 340 m3/h 1150 m3/h

exhaust air flow rate TBD during DQ

nebulizing system dimensions (LxWxH) mm 180x240x155 h

weight of nebulizing system 5 kg

H20

2 flow rate 5 ml/min

H20

2 tank capacity 1 L

user interface touch screen

power supply 230V, 50 Hz - 10A 230V, 50 Hz – 15A

MYBOX iHP

external dimensions* (LxWxH) mm 4100x2400x3600 h

working chamber dimensions* (LxWxH) mm 4000x1500x2200 h

working chamber volume 13.2 m3

class of contamination ISO5 vertical laminar flow according to ISO 14644-1

duration of sterilization cycle 76 minutes (full chamber standard load)

inlet air flow rate 4000 m3/h

ionizing system dimensions (pod) (LxWxH) mm 280x80x120 h

weight of pod 1.2 Kg

H20

2 flow rate 15 ml/min

tank capacity 4 L

user interface touch screen

power supply 230V, 50 Hz

*Customizable upon request

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LAF SYSTEMS

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AIRFLOW DECONTAMINATION SYSTEM

Specialized antechambers which personnel must pass through before entering contamination controlled areas in order to decontaminate. The shower is designed for the entry and exit of one person at a time. The air shower is designed with two doors that are usually open and interlocked at the same time to avoid simultaneous opening. A traffic light on both sides shows door status. Entering the shower from a “not classified” area automatically activates the airflow when the door closes thanks to pre-set cycle.

Emergency buttons inside and outside the air shower allow an immediate halt of the system and open the doors.The air shower can also be used to decontaminate equipment on pallets, allowing it to pass from a not classified area to a classified area (e.g class D). The chamber is kept under negative pressure by means of a suction fan that draws air from the pallet zone.

TECHNICAL SPECIFICATIONS

• structure in AISI 304 stainless steel • HEPA filter, dimensions mm 610x610x292, Eurovent class H14 or H13 for high airflow rates • n. 2 230 V centrifugal fan motors • n. 4 high-speed air barriers (two on each side) • internal light • n. 1 differential pressure gauge: Magnehelic • n. 2 glass doors with electronic interlock

AIR SHOWER

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*Customizable upon request

DOCUMENTATION

Air shower comes with a digital version operating manual that contains:

• proper use procedure • regular maintenance procedure • report of the functional tests performed during the testing phase at our facility • CE certificate of conformity • original certificates of the HEPA filters and fans

RULES AND REFERENCE GUIDELINES

• CEI EN60204-1 • machinery directive 2006/42/CE • electromagnetic compatibility directive 2004/108/CE • low voltage directive 2006/95/CE (applicable to the electrical panel only)

TECHNICAL DATA

external dimensions* (LxWxH) mm 1500x1200x2750 h

working chamber volume (LxWxH) mm 900x1100x1950 h

total airflow 3.000 m3/h

average speed outlet air > 15 m/s

class of contamination ISO5 vertical laminar flow according to ISO 14644-1

power supply 230V one phase, 7 A – 50Hz

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LAF SYSTEMS

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CLASS ISO5 MATERIALTRANSFER SYSTEM

Laf trolleys have been developed to allow safe material transfer from a classified grade A area to another classified grade A area, passing through a classified grade B area with no need for electrical supply (around 30 minutes of autonomy).

Laf trolleys are mainly used to transfer stoppered vials from the vial-filling line to the freeze dryers and then to the vial-capping machines.

Air is drawn from the surrounding environment via side pre-filters, then HEPA filtered, forced to move horizontally through the trolley and finally expelled from slots placed on the doors.

TECHINCAL SPECIFICATIONS

• structure made of AISI 304 stainless steel with Scotch Brite® finishing • HEPA filter with 99.999% efficiency on 0.3 μm particles, Eurovent class H14 • high efficiency flat pre-filters on the lower sides of the trolley with protective grid in stainless steel • fan with pressure and flow rate that ensure a 0.45 m/sec +- 20% speed of air exiting the HEPA filter • integrated electrical panel with general switch, power supply 230V – 50Hz • supports for trays • handles for maneuvering • UPS with lead battery and control valve, autonomy up to 30 minutes. Complete recharge: 8 hours • differential pressure gauge to detect Δp between the plenum and the surrounding area • external connection with closing cap to detect 100% DOP via photometer • external connection with closing cap for HEPA filter efficiency test tracer, connected to the fan • electrical wire mt 3 with 2P+T 230V 16A socket • n. 4 swivel castors with foot guards, maximum capacity 250 kg/each • n. 2 doors in transparent acrylic with holes for air exhaust

LAF TROLLEY TRANSPORT SYSTEM

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TECHNICAL DATA

external dimensions* (LxWxH) mm 650x1100 (+100 for handles)x1650 h

working chamber dimensions (LxWxH)* mm 500x700x660

supports for trays* n. 5

trays* n. 10 for each support

pitch* mm 60 variable

total airflow 450 m3/h

class of contamination ISO5 according to 14644-1

power supply 230V 1kW, 7 A – 50Hz

*Customizable upon request

DOCUMENTATION

Laf trolleys come with a digital version operating manual that contains:

• proper use procedure • regular maintenance procedure • report of the functional tests performed during the testing phase at our facility • CE certificate of conformity • original certificates of the HEPA filters and fans

RULES AND REFERENCE GUIDELINES

• CEI EN60204-1 • machinery directive 2006/42/CE • electromagnetic compatibility directive 2004/108/CE • low voltage directive 2006/95/CE (applicable to the electrical panel only)www.am

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LAMINAR FLOW CABINETS

Laminar flow cabinets are made of AISI 304 stainless steel and are equipped with ventilation and air filtering systems to guarantee ISO5 conditions inside the area when doors are closed. Scotch Brite® finishing for both external and internal surfaces. Customizable dimensions.

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AM Instruments srlVia Isonzo, 1/c

20812 Limbiate (MB) - ItalyTel. +39 02 872892.1

Fax +39 02 872892.00

aminstruments.cominfo@aminstruments.com

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