Together always one step ahead

PSI-L – Changes Like a Chameleon Modular and flexible production isolator

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SKAN

SKAN, founded in 1968, is one of the pioneer companies in the field of cleanroom equipment and design of isolators for the pharmaceutical industry.

Innovative products, client specific solutions as well as an efficient service organization have made SKAN a market leader and important partner of industry and research laboratories worldwide.

PSI-L for small scale filling

Your needs

�� Small scale production of clinical samples, stability batches or low volume parenterals�� Aseptic working conditions with highest sterility assurance�� Operator safety for working with toxic substances�� Vial filling, stoppering and capping�� Syringe filling, stoppering�� Optional lyophilization process

Our solution

The Pharmaceutical Safety Isolator L-flange, PSI-L, is a modular isolator system with a unique L-shaped flange, which allows working equipment to be exchanged very quickly. The short decontamination cycle and the optional return air filter (FIPA) makes it a universal, sterile workspace for aseptic and/or highly active pharmaceutical products.

Features

�� Modular isolator PSI-L endowed with fast and easy to exchange filling equipment�� The possibility of using an empty flange plate guarantees maximum flexibility for manual operations�� Aseptic production through H2O2 decontamination of the isolator�� Fast H2O2 decontamination of the air lock < 20 min for quick inserting of pharmaceutical ready-to-use packaging material into the isolator�� Excellent operator safety by changeable FIPA return air filters�� Suitable for many different sizes and types of pre- sterilized packaging material

Great variety of possible combinations

Many different combinations of the modules are possible, due to the requirements of the production process. In addition, the flanges within the modules can be changed very quickly.

Depending on the manufacturing process, input is possible via mousehole, fast H2O2 airlock SARA (suitable for RTU ready-to-use packaging material) or hot air tunnel, output via mousehole, H2O2 airlock SARA or bag-out system.

The L-flange will be delivered empty for different purpos-es or can be totally adapted for customer processes. Back wall, base frame and work bench can be filled with indi-vidual laboratory equipment like scales, incubators, mix-ers, sensors, pipings, WFI and electrical connections. Large process equipment, like vessels, RTP, freezers and hot air ovens can be interfaced with pressure tight flanges.

Insertion of the exchangeable L-flange (marked red) PSI-L with installed exchangeable L-flange

Flexible use of the empty flange

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The filling equipment installed on the L-shaped flange is inserted into the isolator (1). All required material for the filling process is loaded into the quick decontamination airlock and automatically decontaminated with H2O2 (2). After successful decontamination, the material is transferred into the working chamber and unpacked (3). The vials or syringes can now be weighed in an empty state and filled (4). To guarantee accurate filling quantity, the vials or syringes are weighed again after filling (5). With special tools the vials can be stoppered (7) and capped manually or semi-automatically (8). The finished products can be stored in a tray and transferred either via a second airlock, a mousehole or bag-out system from the isolator.

For the pharmaceutical industry highly toxic products in barrier isolators are becoming increasingly important. Safe product handling and operator protection are essential. State-of-the-art safe change filter systems are needed to meet these requirements. FIPA is a safe and comfortable changeable filter cartridge for toxic aseptic barrier isola-tors, based on continuous design improvements. The PSI-L in the version with additional FIPA filter in the recirculation air is suitable for usage with manual spray gun and wet wash down cleaning.

Manual and semi-automatic fillingProcessing of toxic products

Example: semi-automatic fillingToxic version with safe change filter cartridge

FIPA safe change filter cartridge

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Automatic Vial Processing

The filling machine installed on the L-shaped flange is inserted into the isolator (1). All required material for the filling process is loaded into the quick decontamination airlock and automatically decontaminated with H2O2 (2). After successful decontamination, the material is transferred into the working chamber and unpacked (3). Vials can now be filled and the stoppers put on according to the following production steps (4). If freeze drying is applied the stoppered vials are transferred to the second isolator section, where the freeze dryer is attached to the back wall (5). The vials are loaded into the freeze dryer manually and are processed automatically. After the lyophilization process has been completed, the fully closed vials are capped in the capping station (6). The finished pro-ducts can then be transferred either via a second airlock, a mousehole or a bag-out system from the isolator (7).

Input possibilities:

hot-air tunnelH2O2 airlock SARA

Output possibilities:

mousehole

washing machine hot-air tunnel SARA filling / stoppering station two freeze dryers (extendable) capping station

Vial filling with lyophilization process

Large quantity vial solution for bulk vials

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Automatic Vial Processing

Small to large scale vial filling

By washing machine with hot air tunnel or fast airlock:

The filling machine installed on the L-shaped flange is in-serted into the isolator (1). The vials run through the wash-ing machine (2), are dried with compressed air (3) and are siliconized (4). For sterilization the vials are heated up (5), then kept at defined temperature (6) and afterwards cooled down (7) inside of the hot air tunnel. All required material for the filling process can be loaded alternatively into the decontamination airlock and automatically de-contaminated with H2O2 (8). The vials are transported to the filling machine where they are automatically filled (9), stoppered (10) and capped (11). Afterwards, the finished products are transferred through a mousehole to the cleanroom (12).

Input possibilities:

mouseholeH2O2 airlock SARA

Output possibilities:

mouseholeH2O2 airlock SARA

bag-out system

Alternative small solution with ready-to-use material (RTU)

H2O2 transfer vial filling plus stoppering and capping station

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Automatic Syringe Processing

The filling equipment installed on the L-shaped flange is inserted into the isolator (1). All required material for the filling process is loaded into the fast decontamination air-lock and automatically decontaminated with H2O2 (2). In the first chamber the outer foil of the tub with the nested syringes is removed (3). Alternatively, a tub unpacking sta-tion can be installed at the rear of the isolator, in which the tubs are unpacked automatically. Afterwards, the welded Tyvek® layer is pulled off (4) and the loose cover sheet is removed (5). In the second isolator chamber the syringe nest is lifted out of the tub (6). The syringes are filled (7) and the stoppers are put on (8). Before leaving the isolator the syringe nest is relocated into its tub (9). The finished products can then be transferred either via a second air-lock or via a mousehole out of the isolator.

Presterilized syringes in tub processing

Input possibilities:

mouseholeH2O2 airlock SARA

Output possibilities:

mouseholeH2O2 airlock SARA

Alternative small solution with ready-to-use material (RTU)

H2O2 transfer syringe filling plus stoppering station

SKAN AGBinningerstrasse 116CH-4123 AllschwilT +41 61 485 44 44F +41 61 485 44 45info@skan.chwww.skan.ch

SKAN Japan3008-2, GusukumaUrasoe-City, 901-2133Okinawa, JapanPhone +81 98 894 2636info@skan.ne.jpwww.skan.ch

SKAN US, Inc.7409 ACC Blvd., Suite 200Raleigh, NC 27617, USAPhone +1 919 354 6380sales@us.skan.ch www.us.skan.ch

SKAN BI®

The biological indicator for H2O2 decontamination: Designed for outstanding performance.

WirelessGT

The innovative glove leak testing system without tubes and wires: It´s better to be wireless.

Suitable Products:

Changes may be made as a result of technical progress or improvements in services offered.

PSI-L Brochure EN Material No. 1211640

Version 199522_D / 20140604