SAS for clean rooms

Pass-boxes

SAS (Safety Access System) are equipment used in clean rooms for the transfer of materials.

Thanks to interlocking mechanisms between the doors, they prevent air cross-contamination while maintaining the classification of the different environments they connect.

Also known as Pass Boxes, Cleanroom Pass Through, Clean Transfer Windows or Transfer Hatches, pass-throughs can be static or dynamic, single or double and equipped with mechanical transfer devices or decontamination systems, among others.

To ensure that each equipment meets the requirements of each installation, at Kirhtech we design and manufacture them according to your needs.

AISI 304 stainless steel

HEPA 14 or ULPA filters

Control panel with pressure gauge

Magnetic interlocking

SAS de salida de producto acabado y residuos

AISI 304 stainless steel

Technical cabinet

Control touch screens

Waste outflow

Finished product output

SAS for clean rooms

Finished product and waste output SAS

Totally compact equipment for the output of Finished Product and Waste from the clean room of higher classification to one of lower classification.

General characteristics

The upper part is intended for the output of finished product and the lower part for waste, the equipment consists of a first Class B chamber and then a Class C chamber.

Each unit is equipped with an automatic finished product transfer system with a transferable load of 120kg and a waste transfer system with a load of 50kg.

These chambers are separated by an automatic intermediate door and are equipped with the necessary elements to maintain the B and C classification according to GMP and the pressure differential.

Manufactured entirely in AISI-304 and AISI-316 stainless steel with a vibratory polished finish meeting the highest standards of the pharmaceutical industry.

It has a technical area on one side that facilitates maintenance work.

It consists of 2 totally independent SAS units that meet the requirements of GMP and ISO 14644 standards, as well as RD 1215/1997.

The control system is fully automatic, provided with HMI screen and PLC control connected to a SCADA system.

The control system has been designed, manufactured and validated according to GAMP 5 and Annex 11 GMP.

Electronic records comply with 21 CFR Part 11.

SAS for clean rooms

SAS for raw material input with H2O2 decontamination

Completely compact equipment for the entry of raw materials from the clean room of lower classification to the higher classification, by means of a surface biodecontamination system by H2O2 cold nebulization.
General characteristics

It has a chamber with a volume of 2m3 where 3 double levels of trays are loaded with the product to be decontaminated, the loading is done by means of transport carts adapted to the equipment.

The system has several operating cycles depending on the stage of the process: resting, conditioning, injection, exposure, aeration or tray return.

Each chamber is equipped with the necessary elements to maintain the B classification according to GMP and the pressure differential continuously, as well as the temperature and humidity necessary for decontamination.

The doors of the chambers are equipped with pneumatic seals to guarantee watertightness.

Manufactured in AISI-304 and AISI-316 stainless steel with a vibratory polished finish meeting the highest standards of the pharmaceutical industry. It has a technical area on one side that facilitates maintenance work.

It consists of 2 totally independent SAS units that meet the requirements of GMP and ISO 14644 standards, as well as RD 1215/1997.

The control system is fully automatic, provided with HMI screen and PLC control connected to a SCADA system. The control system has been designed, manufactured and validated according to GAMP 5 and Annex 11 GMP.
Electronic records comply with 21 CFR Part 11.

P.M.E.

SAS Static Material Feeders

Kirhtech’s SAS (safety access system) static pass-through systems are recommended for transfers between classified and/or unclassified rooms.

They are made of AISI 304 stainless steel, have interlocking between doors and are not equipped with an absolute filtration system.

Interlocking between doors can be done by time delay. UV radiation for product decontamination is available as an option.

We design and manufacture each Static SAS according to the requirements of each project.

General characteristics
Optional features

P.M.D.

SAS Dynamic Material Handlers

Kirhtech’s SAS (safety access system) dynamic material pass-throughs are designed for safe transfer of materials between classified areas of both the same and different classifications.

They are made of AISI 304 stainless steel, have interlocking between doors, and are equipped with an absolute filtration system guaranteeing a class inside the SAS ISO 5 during the controlled opening process with electromagnetic interlocking between doors.

They are also equipped with an air inlet for air supply from an existing HVAC system and a HEPA H14 filtration module.
We design and manufacture each Dynamic SAS according to the requirements of each project.

General characteristics
Optional features
Decontamination

P.M.A.

SAS Pasamateriales Autónomos

General characteristics

Kirhtech’s self-contained SAS (safety access system) material pass-throughs are designed to safely transfer materials between classified areas of both the same and different classifications.

They are made of AISI 304 stainless steel, have interlocking between doors, and are equipped with an absolute filtration system guaranteeing a class inside the SAS ISO 5 during the controlled opening process with electromagnetic interlocking between doors.

They can be installed in the classified room autonomously without the need to be connected to the existing HVAC system thanks to a room air suction grille, a supply unit with EC technology and a HEPA H14 filtration module.

We design and manufacture each stand-alone SAS according to the requirements of each project.

General characteristics
Optional features
Decontamination

P.M.D.D.

SAS Dynamic Double Material Feedthroughs

Kirhtech’s SAS (safety access system) dynamic material pass-throughs are designed for safe material transfer.
between classified areas of both the same and different classifications.

They are made of AISI 304 stainless steel, have interlocking between doors, and are equipped with an absolute filtration system guaranteeing a class inside the SAS ISO 5 during the controlled opening process with electromagnetic interlocking between doors.

They are also equipped with an air inlet for air supply from an existing HVAC system and a HEPA H14 filtration module.
We design and manufacture each Double Dynamic SAS according to the requirements of each project.

General characteristics
Optional features
Decontamination

P.M.M.

SAS Pasamateriales de Mazacotes

Compact equipment for the evacuation of materials distributed in two independent SAS for each product from the filling room (clean room) to the plant where they will be collected and subsequently transferred (gray room).

Composed of an external structure of sanitary panel, PVC canvas roll-up doors and automatic gates.

Connectable to the cleanroom HVAC system.

General characteristics
SAS de mazacotes PMMR

P.M.R.

SAS Material Handler with Roller

Compact equipment designed for the entry and exit of materials from the classified area to the unclassified area, ready to be installed in a clean room, as it can be connected to the HVAC ventilation of the room.

Composed of an external structure of sanitary panel with A-s1-d0 fire resistance and carbon steel structural profile, two sets of conveyors for the movement of pallets and three rapid roll-up doors made of PVC canvas, which delimit the spaces of SAS 1 and SAS 2.

External structure: RAL 9010 lacquered galvanized steel sandwich panel with rock wool core.

Internal structure: in lacquered steel and stainless steel.

General characteristics

P.M.S.P.A.

Finished product output SAS

General characteristics

Completely compact equipment for the output of Product from the clean room of higher classification to one of lower classification.

It consists of a chamber and the necessary elements to maintain the C classification according to GMP and the pressure differential inside it. A top-opening sliding door has been designed and manufactured to seal the SAS during production shutdowns.

The SAS is ready to be installed and integrated in a clean room, as it is connectable to the HVAC ventilation of the room.

Manufactured entirely in AISI-304 and AISI-316 stainless steel with a vibratory polished finish meeting the highest standards of the pharmaceutical industry.

It has an upper technical area that facilitates maintenance work.
It complies with the requirements of GMP and ISO 14644 standards, as well as RD 1215/1997.

The control system is fully automatic, provided with HMI screen and PLC control connected to a SCADA system.

The control system has been designed, manufactured and validated according to GAMP 5 and Annex 11 GMP.

P.M.S.R.

SAS waste outfeed material pass-through

General characteristics

Compact equipment for the exit of waste from the classified area to the unclassified area, consisting of a first Class C chamber and then a Class D chamber.

The sas is ready to be installed in a clean room, as it is connectable to the HVAC ventilation of the room.

Composed of an external structure of sanitary panel with A-s1-d0 fire performance and carbon steel structural profile, it consists of an elevator and bucket turner assembly with the material to be discarded and three PVC canvas roll-up doors, which delimit the SAS 1 and SAS 2 spaces.

The outer structure is made of white lacquered steel sandwich panel with rock wool core, the inner structure is made of lacquered steel and the lifting and turning equipment is made of AISI-304 stainless steel.

It has a technical area on one side that facilitates maintenance work.

It complies with the requirements of GMP and ISO 14644 standards, as well as RD 1215/1997.

The control system is fully automatic, provided with HMI screen and PLC control connected to a SCADA system. The control system has been designed, manufactured and validated according to GAMP 5 and Annex 11 GMP.

Electronic records comply with 21 CFR Part 11.

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