Project Description

PHARMACEUTICAL ISOLATOR TESTING

Isolators in the pharmaceutical environment are used to produce and test sterile drug products with a minimised risk of microbiological contamination from the surrounding. Isolators realise a separated aseptic core practically free of microorganisms, what offers maximised protection for production and testing. For the realisation of such an isolated aseptic core, considerations in microbiology play a crucial role in the validation, maintenance and control of the asepsis of an isolator.

Isolators are considered as local exhaust ventilation systems under COSHH and as such are required to have regular examination and testing at intervals of not more than 14 months. Every employer who provides MSCs, LEVs and Fume Cupboards MUST ensure “It is maintained in an efficient state, in efficient working order, in good repair and in a clean condition” – Regulation 9-1 COSHH

Types of isolators tested are:

Positive pressure pharmaceutical isolators are separative devices used for the aseptic preparation and dispensing of IV additives and TPN’s, the isolator provides a full barrier protection between operator and product. The main work area maintains air quality levels in accordance with Grade ‘A’ EU GMP (Class 100) this is supplied via a HEPA filter providing unidirectional airflow. All isolators from CAS come complete with interlocked type ‘D’ transfer hatches

Negative pressure pharmaceutical isolators are separative devices used for the safe handling of cytotoxic drugs and to retain other process generated particles, the isolator provides a full barrier protection between operator and product. The main work area maintains air quality levels in accordance with Grade ‘A’ EU GMP (Class 100) this is supplied via a HEPA filter providing unidirectional airflow. All isolators from CAS come complete with interlocked type ‘D’ transfer hatches

Pharmaceutical isolators are separative devices which separate a pharmaceutical process or activity both from the operator and the surrounding environment. Both inlet and extract air are HEPA filtered through the pharmaceutical isolator to provide aseptic working within the controlled workspace plus environmental protection. Interlocked transfer hatches provide means of entry and exit to and from the controlled workspace

Flexible Film Isolators (FFIs) are tented enclosures of flexible plastic built on a metal frame. They are routinely accessed from the side through gauntlets or sleeves with cuffed gloves. Ports allow material to both enter and exit the isolator. The size of these units and therefore the amount of equipment within is limited by the degree of access afforded by the gauntlets

These are essentially the same as FFI’s except their canopies are made of a rigid material

These are larger than FFIs and are accessed by the operator by half suit(s) in the base of the isolator and also by gauntlets/sleeves and gloves on the side. Operators enter the half suit by ducking under the base and then standing up within the positively pressurised suit. This combination gives the potential for large work surfaces within the isolator due to the increase in accessibility

These are essentially the same as flexible half suits isolators except their canopies are made of a rigid material. This makes them more resistant to damage, but less able to absorb pressure fluctuations, for example when entering or exiting the half suits

These are FFIs or rigid isolators used specifically for transferring materials from one isolator/MSC to another. They are usually battery powered and have docking ports to enable attachment and transfer

Our isolator service tests are carried out in accordance to BS EN 12469 standards. All instruments used in testing are calibrated to UKAS national standards and copies of certification are supplied with reports

Our isolator testing includes:

  • Inspection of the canopy, gauntlets/ sleeves and gloves and/or half suit

  • Monitoring of manometers

  • Check isolator internal condition

  • Check isolator surfaces including the extract ducting

  • Integrity of canopy test

  • Integrity of gauntlet / gloves test

  • Check alarms

  • Anti-blowback valve test

  • HEPA filter leak test (DOP) tested to BS EN 1822:2000

  • Integrity of filter and housing check

  • Inlet filter test

  • Calibration of manometers

  • Inspect pre filters (replace as required)

  • Check cabinet functions

  • Check cabinet electrical components

  • Check air velocities

  • Air change rates

  • Particle counts

  • Issue test certification

  • Full report with photographic evidence

Optional extras:

  • Pressure decay test

  • Light level test

  • Sound level test

Our collaborative and proactive approach drives efficiency, cost savings and offers our clients peace of mind. We are committed to continuous improvement, through innovation and investment in our personnel, methodologies and equipment.

We offer extremely competitive rates and daytime or evenings to offer minimal disturbance to our customers.

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RJ Urmson Commissioning Engineers Ltd
Kellett Street Works
Fellery Street
Chorley
PR7 1EL

T: 01257 262 683
E: sales@rjurmson.com

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      Do you have previous reports available?
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      Do you have ventilation drawings available?
      YesNo

      When would you like the work to be carried out?
      Working hoursOut of hours / EveningsWeekends

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