Gamlen SafeTab Plus

Operator protection combined with a controlled humidity environment

The Gamlen SafeTab Plus combines the safety features of the Gamlen SafeTab with the humidity control of the Gamlen CHE (controlled humidity environment). This allows you to understand the effect of humidity on your APIs, excipients and formulations while providing users with a high standard of respiratory and dermal protection.

Humidity affects the compressibility of key pharmaceutical ingredients and moisture sensitive materials must be studied under actual manufacturing conditions. Now you can dry-granulate, mill, compact and pack tablets without risk to your moisture-sensitive materials while ensuring operator safety. The SafeTab Plus facilitates the safe handling of OEL class 4 and 5 materials as well as cytotoxic APIs. It is ideal for small scale GMP manufacture, material characterisation, pre-formulation, formulation and process development, QbD for tablets and QC of incoming APIs and excipients.

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Key Features

  • Operates between 0 and 98% RH
  • Humidity control ±0.7% RH
  • 0.1 °C temperature resolution
  • Fast set up and simple operation
  • Easy change water reservoir system
  • Can be used with an inert gas
  • Humidity generator requires dry air supply and AC power only
  • Operator protection
  • Suitable for OEL 5 and cytotoxic materials
  • Proven performance
  • Suitable for small scale tablet manufacture
  • Size is customised to requirements
  • Wide range of options and accessories
  • Can be used for a range of testing techniques

GenRH-A: Ambient RH Generator

The GenRA-A is the world’s most flexible instrument for precision ambient RH generation. It is combined with the Gamlen SafeTab containment system to create the Gamlen SafeTab Plus.

Benefits

  • state-of-the-art capabilities
  • highly cost-effective
  • compact instrumentation
  • 0 to 98% RH at ambient temperatures
  • ±0.7%RH control.

Zone 1 Entry Airlock:

double zipper ante-chamber that permits clean items, containers and cleaning materials to be added

Zone 2 Product Handling Chamber:

double doors allow the inbound items into the Product Handing Chamber where they can be processed according to your operations

Zone 3 Exit Bag Liner:

permits items that may have slight surface contamination to exit the PHC with no loss of containment or air escape

SafeTab Plus systems are set up to assure containment

The SafeTab Plus operates with a simple negative pressure airflow system for added assurance that materials cannot escape if a tear or glove split occurs. The airflow system is designed to create a 0.5 m/s capture velocity across a fully open glove cuff. This velocity is proven to prevent particulate escape from isolation systems. All SafeTab Plus isolators are inflation tested to 330 Pa pressure to ensure the enclosure is gas tight. The SafeTab Plus can also be supplied as a Nitrogen or Argon inerted chamber that may be vented or simply maintained as an inflated enclosure.

Quick and easy set up

The Gamlen SafeTab Plus provides equivalent containment to a hard-shell isolator that can be built and operating in less than an hour.

Cost effective, the SafeTab Plus can be shipped flat-packed to your facility for set up by in-house technicians.

Alternatively we offer a full service option that includes:

  • Site assembly and set up
  • Operator training for potent compound handling
  • HEPA filter and air flow validation
  • IQ / OQ Material certification for regulatory compliance