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PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS Assuring the quality of your processes

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Page 1: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

Assuring the quality of your processes

Page 2: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

When working in controlled environments with different levels of classification is essential to have the required means to enable the transit of materials and persons without compromising the classification of each area.

The STERILTECH PASS THROUGH CHAMBERS AND TRANSFER HATCHES are specially designed chambers that enable the transfer of material between areas of different classification level without compromising the cleanness of the different zones that they connect. Furthermore, the STERILTECH Transfer Hatches avoid the cross contamination in the inlet and outlet of materials as regards to the controlled area.

STERILTECH has designed different types of transfer hatches that fulfill the specific requirements of each application.

TYPES OF TRANSFER HATCHES

IMMERSION Decontamination by liquid immmersion.

GERMICIDE Transfer of materials

with germicide U.V. light option.

VENTILATED For he connection of

zones whit different classification level.

BIOLOGICAL For those aplications

requiring biological seal.

BIODECON-TAMINATION

For integrated processes that requires a fast decontamination.

Assuring the quality of your processes

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STERILTECH GLOBAL INNOVATIONS

The IMMERSION TRANSFER HATCHES are used in the bio-contention laboratories for the transfer of materials from contaminated areas to clean areas, through a sterilizing process consisting in the immersion into a biocide solution. They are made in stainless steal AISI-304 or AISI-316, resistant to the usual sterilizing solutions according to the INSHT. Chamber and tank are manufactured according to the requirements of each installation.

• Single piece made in order to get the highest contention level. • Inner chamber and tank with round corners for better cleanability. • Glass window in doors. • Face to face doors design or "L" configuration as an option. • Doors closing system with pressure gasket or inflatable gasket

according to the requirements of each installation. • Electromagnetic interlocking system to avoid the simultaneous

opening of both doors. • Emergency door unblocking system independently activated from the

outside and, according to the chamber dimensions, also from the inside as an option.

• Doors state signaling. • Microprocessor control of time and other parameters.

! UV germicide lamps inside the chamber controlled from both sides and automatic turn off in case of door opening.

! Chamber lightening controlled from both sides.

! Ventilation system with H14 HEPA filters

for both the air impulsion and extraction. ! Touch screen. ! State of process indication by four

different colors of chamber lighting: ready for use, decon cycle in progress, end of cycle, and error.

! Tank level indicators. ! Tank filling and tank emptying

automation. ! CAMLOCK connectors for the connection

of Hydrogen Peroxide Vapour (VHP) generators.

! Uninterrupted power supply (UPS)

system.

OPTIONS

QUALITY ASSURANCE Steriltech designs and builds its transfer hatches under the following criteria: low consumption, robustness, compactness, lowest number of parts possible, cleanability and maintenance ease.

Our priority is to understand the end user requirements, in order to assure that the installation of the transfer hatch is going to increase the efficacy, agility and safety of the processes, without compromising the conditions of the different areas that it will be connecting.

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STERILTECH GLOBAL INNOVATIONS

The GERMICIDE PASS THROUGH CHAMBERS are intended to enable transference of materials between areas of different classification, while avoiding the transit of persons. The decontamination cycles are carried out by germicide UV light UV-C.

The GERMICIDE PASS THROUGH CHAMBERS or windows are available in AISI 304 stainless steel (or AISI -318 as an option), and in different dimensions that can meet the requirements of each installation.

• Both the working chamber and the housing are made in one single piece, in order to provide the highest containment grade always. The absence of joints and gaskets means no weak points and maintenance free.

• Working chamber and external doors with wide radius round corners, designed for better cleanability avoiding particle deposits.

• Doors with pressure joints and electromagnetic interlocking for the safe transference of materials between areas of different classification.

• Hands free door handling. • Door state signaling. • Securized glass doors, with UV protection. • Germicide UV lamps inside the chamber, than can be controlled from

both sides. • Security system that turns the UV light off if any door is opened.

! AISI 316 Stainless Steal.

! Connection kit for Hidrogen Peroxide Vapour Generator (HPVG), including CAMLOCK connectors for the execution of decontamination cycles.

! Face to face or "L" configuration for

the doors.

! Touch screens with different menus and access levels.

! Kit for column installation.

! Installation at low level design.

! Sanitary aluminum enclosure.

! Stainless steel legs.

! UPS (Uninterrupted Power Supply).

MODEL DIMENSIONS (W x H x D) mm

WORKING CHAMBER EXTERNAL DIMENSIONS ST-SASG404040 400x400x400 620x540x400 ST-SASG505050 500x500x500 720x640x500 ST-SASG606060 600x600x600 820x740x600

OPTIONS

Page 5: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

! AISI 316 Stainless Steal.

! Hydrogen Peroxide Vapour Generator (HPVG), including CAMLOCK connectors for the execution of decontamination cycles.

! Face to face or "L"

configuration for the doors.

! Touch screens with different menus and access levels.

! Kit for column installation.

! Installation at low level design.

! Sanitary aluminum enclosure.

! Stainless steel legs.

! UPS (Uninterrupted Power

Supply).

MODEL DIMENSIONS (W x H x D) mm

WORKING CHAMBER EXTERNAL DIMENSIONS ST-SASV404540 400x450x400 790x780x400 ST-SASV505050 500x500x500 890x830x500 ST-SASV606060 600x600x600 990x930x600 ST-SASV607060 600x700x600 990x1030x600

The VENTILATED PASS THROUGH CHAMBERS are used for the transfer of materials between areas with different classification level, avoiding the transit of persons. The potentially contaminated air that get into the pass through chamber during the load and unload of materials is continuously filtered in order to reduce the level of particles and to keep the classification grade of the communicated rooms. They also enable the execution of decontamination cycles through germicide UV-C light.

The VENTILATED PASS THROUGH CHAMBERS are available in AISI-304 stainless steal or AISI-316 (as an option), and in different dimensions in order to fulfill the requirements of each installation.

• Both the working chamber and the housing are made in one single piece, in order to provide the highest containment grade always. The absence of joints and gaskets means no weak points and maintenance free.

• Working chamber and external doors with wide radius round corners, designed for better cleanability avoiding particle deposits.

• Doors with pressure joints and electromagnetic interlocking for the safe transference of materials between areas of different classification.

• Hands free door handling. • Door state signaling. • Low consumption motor-fans with ultra-filtration system (H-14), in

order to assure the highest efficiency of the process. • Securized glass doors, with UV protection. • Germicide UV lamps inside the chamber, than can be controlled

from both sides. • Optimized cycles timing.

OPTIONS

Page 6: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

The BIOLOGICAL TRANSFER HATCHES are barrier equipment that enable the transfer of materials between areas with different level of biological contention. They are specially designed for the biodecontamination of materials by using disinfectants o vaporized biocide agents.

The BIOLOGICAL TRANSFER HATCHES can be used with Hidrogen Peroxide Vapour (HPV) generators in order to execute sterilizing cycles that get a 6-log bioburden reduction on all the surfaces of chamber and load. Furthermore, the transfer hatch can be also used without the HPV generator in order to execute sterilizing cycles with other sterilizing agents or biocides and also to carry out biodecontamination cycles using germicide UV light.

• Available in both stainless steel AISI-304 and AISI-316 (Optional). • Custom made working chamber with loading and unloading system

designed for every application. • Special doors design which allows the loading at floor level without pit. • Two gas tight doors with securized glass windows,

inflatable gaskets and interlocking device with electromagnetic blocking, in order to prevent the simultaneous opening of both doors, so that the contaminating particles can never travel between the interconnected areas.

• The inner chamber surfaces are high grade polished stainless steel and with wide radius round corners, preventing any deposit of contamination and enabling an easy and thorough cleaning.

• Germicide UV lamps inside the chamber with doors interlocking system for the automatic disconnection in case of door openings.

• Gas tightness between the different zones through double biological seal.

• Gas tight plenums in order to avoid unwanted contaminations out of the working chamber.

• Ventilation system using low consumption motor-fans and ultra-filtration by H-14 absolute filters.

• Safe unblocking system for emergency situations that can be independently activated either from the inside or the outside in order to avoid the accidental occupation of the working chamber.

BIOLOGICAL TRANSFER HATCH

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STERILTECH GLOBAL INNOVATIONS

Control system: • 10 ,4" colour touch screen in both work ing s ides . • The human-machine interface (HMI) is highly intuitive and very

user-friendly. • Fully automatic control. • Icons indicating the doors state and if the gaskets are inflated. • Icons indicating the phase of the cycle. • Indication of the selected cycle. • Indication of current phase of the cycle. • Indication of properly completed cycle. • Warning alarms. • Access restriction by security code (optional).

! 2 doors chamber in "L". ! 3 doors chamber. ! Hydrogen Peroxide Vapour

Generator. ! Process Videorecorder meeting

the 21 CFR Part 11 requirements. ! Integrated H2O2 catalyst for

installations where the exhaust connection to the outside is not possible.

! Bidirectional communication kit for active monitoring with CAMLOCK connections for the use of Hydrogen Peroxide Vapour generators (HPV).

! Uninterrupted Power Supply system (UPS).

MODEL DIMENSIONS (W x H x D) mm

WORKING CHAMBER EXTERNAL DIMENSIONS ST-SASBIO 135x220x230 1350x2200x2300 1930x3260x2420 ST-SASBIO 135x220x200 1350x2200x2000 1930x3260x2320 ST-SASBIO 155x227x232 1550x2270x2320 2070x3260x2440 ST-SASBIO 120x220x120 1200x2200x1200 1320x3000x1800

The following categories of cycles can be selected in the control menu:

• User-selectable aeration cycle. • Safety areation cycle. • 2 cycles designed for the use of an internal generator. • 2 cycles designed for the use of an external generator. • Interactive cycle of smart parametric control with integrated

Hydrogen Peroxide Vapour generator. With this feature up to 100 different cycles can be defined (load, time, etc.).

• Transfer hatch cycle for the pass through of materials from clean room to unclassified area, for optional activation according to users requirements.

OPTIONS

Page 8: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

The BIODECONTAMINATION TRANSFER HATCHES are compact systems intended for the transfer of materials between areas of different classification, through the automatic execution of sterilizing cycles using Hidrogen Peroxide Vapor (HPV) under controlled conditions that get a 6-log bioburden reduction on all the surfaces of chamber and load, The control system continually monitors all the parameters of the process during each phase of the biodecontamination cycle: conditioning, injection, contact and ventilation. In order to verify its effectiveness the biodecontamination cycles can be validated through chemical and biological indicators. The duration of the cycles is dramatically shorter compared to other alternative technologies, with lower H2O2 consumption and it is totally residue-free. This biodecontamination technology has proved its effectiveness, security and compatibility with all kind of materials during years.

A HPV generator integrated in the BIODECON TRANSFER HATCH makes possible the execution of the sterilizing cycles through the optimized distribution of HPV. Furthermore, the transfer hatch can be also used without the HPV generator in order to execute ventilation cycles or carry out biodecontamination cycles using germicide UV light.

Page 9: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

• Integrated Hydrogen Peroxide Vapour generator. • Available in both stainless steel AISI-304 and AISI-316

(Optional). • Custom made working chamber with loading and unloading

system designed for every application. • Special doors design which enable the loading either at

floor level or at any height required by any specific installation.

• Two gas tight doors with secured glass windows, inflatable gaskets and interlocking device with electromagnetic blocking, in order to prevent the simultaneous opening of both doors, so that the contaminating particles can never travel between the connecting areas.

• The inner chamber surfaces are high grade polished with wide radius round corners, preventing any deposit of contamination and enabling an easy and thorough cleaning.

• Germicide UV lamps inside the chamber with doors interlocking system for the automatic disconnection in case of door openings.

• Sate of art LED lighting inside the chamber. • The LED lighting of the inner chamber changes at every

phase of the cycle, making possible the remote identification of the cycle state through the door window.

• Gas tightness between the different zones through double biological seal.

• Gas tight plenums in order to avoid unwanted contaminations out of the working chamber.

• Ventilation system using low consumption motor-fans and ultra-filtration by H-14 absolute filters.

• Safe unblocking system for emergency situations that can be independently activated either from the inside or the outside in order to avoid the accidental occupation of the working chamber.

Page 10: PASS THROUGH CHAMBERS, TRANSFER HATCHES ...steriltech.net/gi_eng/files/PASS-THROUGH-CHAMBER-AND-TRANFER... · PASS THROUGH CHAMBERS, TRANSFER HATCHES, BIODECONTAMINATION CHAMBERS

STERILTECH GLOBAL INNOVATIONS

Control system:

• 10,4" colour touch screen in both working sides. • The human-machine interface (HMI) is highly

intuitive and very user-friendly. • Fully automatic control. • Icons indicating the doors state and if the gaskets

are inflated. • Icons indicating the phase of the cycle. • Indication of the selected cycle. • Indication of current phase of the cycle. • Indication of properly completed cycle. • Warning alarms. • Access restriction by security code (optional).

The following categories of cycles can be selected in the control menu:

• User-selectable aeration cycle. • Safety aerations cycle. • Interactive cycle of smart parametric control with

integrated Hydrogen Peroxide Vapour generator. With this feature up to 100 different cycles can be defined (load, time, etc.).

• Transfer hatch cycle for the pass through of materials from clean room to unclassified area, for optional activation according to users requirements.

Hydrogen peroxide loading system with RFID label reader for the automatic recognition of the production batch used in order to assure the traceability of the whole process.

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STERILTECH GLOBAL INNOVATIONS

OPTIONS ! Mobile HPV generator.

! Process Videorecorder meeting the 21 CFR Part 11

requirements.

! Integrated H2O2 catalyst to speed up the aeration phase of the biodecontamination cycle.

! Uninterrupted Power Supply system (UPS).

High efficiency fast and safe connections with closing lids to be used during the maintenance actions or also during long inactivity periods of the system.

LOADING AND UNLOADING SYSTEMS

The transport systems used for the materials transfer within a classified area are elements that must be considered in order to assure the quality of the process. STERILTECH also provides system for the load and unload of transfer hatches, which have been specially designed for each application, having in mind the user ergonomics, the safety of the product during the transport, the ease of chamber loading and unloading, the proper load distribution inside the chamber to optimize its biodecontamination, and also other factors like robustness, cleanability, etc.

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STERILTECH GLOBAL INNOVATIONS

STERILTECH GLOBAL INNOVATIONS

Locations: Laguna del Marquesado, 14 Nave 1.

28021 Madrid (Spain).

Phone: +34 91 710 95 47 / Fax: +34 91 796 65 52

www.steriltech.net/gi_eng/

[email protected]