manufacturer :       PBI

model :                   Sas Super 180

annotation :           Dokumente engl .

Your partner in environmental Microbiology

The very familiar “yellow SAS (Surface Air System)” is considered the international standard for portable air microbiological samplers. Over 25 years experience has been gained in five continents helping microbiologists in the pharmaceutical and food industry, hospital sector and indoor air quality fields. Experience has also been gained from space exploration as the SAS (Surface Air System) was used on board the International Space station.

This knowledge has resulted in the development of the new “SAS SUPER ISO 100” and

“SAS SUPER ISO 180”.

References of SAS - Surface Air System

FDA - 1987 Guideline on Sterile Drug Products by Aseptic Processing

ACGIH - Guideline for the Assesment of Bioaerosols in the indoor Enviroment

ASTM - Draft Protocol - Committee D22.05.06

USP (United State Pharmacopeia) - chapter <1116> - Microbiological Evaluation of Clean Rooms and other Controlled Environments EU Guide for GMP - Manufacture of Sterile Medicinal Products Control of Medicines and Inspection

ISO 14698-1

The basic idea

• To use a simple plate for air and surface sampling
• To have the additional flexibility of choice, either Contact plates or Petri dishes
• To apply cGLP and cGMP to air sampling operations
• To establish data on the microbial level in selected environments
• To organize sequential sampling to obtain a more representative air sample under actual operating conditions

The “SAS SUPER ISO” has the following new features:

• Performance in compliance with ISO 14698-1
• Large LCD with illuminated touch panel
• All operator commands via touch keypad for easier cleaning
• Over 70.000 litres of air / 8 hours autonomy
• Infrared transfer of sampling data to PC or printer
• Up to 300 sampling cycles memorized
• USP chapter <1116> and 21-CFR 11 Compliance
• Sampling rate accurately maintained by speed sensor-incorrect aspiration aborts cycle
• Design avoids turbulence in unidirectional air flow and re-aspiration of tested air in accordance with ISO specifications
• Total traceability
• Bi-directional port to input and output data to a central unit from 1 to 24 samplers
• Automatic time calibration reminder
• Easy calibration monitoring with additional anemometer system
• Sampler can be operated whilst attached to mains

Established “yellow SAS (Surface Air System)” features and performances are maintained:

• Possibility to use 55 mm (RODAC), 84 mm Contact plates or standard disposable 90 mm Petri dishes
• Interval sampling with fully programmable parameters for “in operation” monitoring
• Delay Start of up to 60 minutes
• Infrared remote control (optional extra)
• Certified aspirating head in aluminium or stainless steel
• Multiple language choice
• Reduced sampling time (six or ten minutes for 1000 litres of air)
• Suitability in isolator

Plus a worldwide service and support network which includes:

• International PBI is the only company with its own microbiological wind tunnel to test the air samplers from a microbial point of view
• Complete validation documentation available to help the local validation process
• Product specialists provide on-site training and certification of personnel for the proper usage of the air samplers
• Official factory calibration in Milan performed in 48 hours
• Over 100 Application Notes
• Standard Operating Procedures (SOP)
• I.Q., O.Q., P. Q. documentation or on-site activation