GMP

GMP “Good Manufacturing Practice"
Gram BioLine acknowledges the specialised and specific needs of a GMP area, and with our GMP-application moniker, we labour to help shed light on which Gram BioLine refrigerators and freezers are suited for a GMP area. Ultimately being a small cog in a large wheel, Gram BioLine cabinets contribute in ensuring the lowest possible risks involved in pharmaceutical production that cannot be eliminated through testing.

 

The different Gram BioLine model ranges below, enable the lowering of risks for human consumption of GMP-controlled substances, and at the same time heighten product consistency, with their unique performance in temperature stability and temperature uniformity. 

Our GMP pledge:

  • IQ,OQ,PQ READILY AVAILABLE
  • EXTENSIVE PRODUCT DOCUMENTATION, FOR EASE OF INSTALLATION, VALIDATION AND QC
  • 24H PRODUCT OPERATION TEST, ON ALL BIOLINE PRODUCTS

ExGuard

The ExGuard is designed for safe temperature controlled storage of items potentially emitting noxious, malodourous and /or explosive atmospheres. At the core, the ExGuard is envisioned to facilitate a safer work environment for users.

ExGuard increases work environment safety and allows placement in work environments by letting your existing ventilation system extract the hazardous atmospheres from the cabinet interior prior to you being able to access the interior.

ExGuard

BioUltra

The BioUltra is our ultra-low-temperature cabinet, designed to meet exceptional expectations for safe storage. It has a powerful bottom mounted cascade refrigeration system, vacuum insulated panel technology and safe closing system constituted by multi-tier gaskets placed in a labyrinth frame.

BIOULTRA RANGE

BioPlus

This is our most advanced model, specifically designed to meet even the most stringent biostorage requirements. The compressor is mounted on top of the cabinet, and the interior is made entirely of stainless steel. BioPlus cabinets are available as full–height units with six different capacities.

BioPlus

BioMidi

This is our mid–range model, designed to comply with demanding biostorage requirements. The compressor is mounted at the base of the cabinet, and the interior sides are made of aluminium or stainless steel. All BioMidi models feature a high– specification control system.

BioMidi

BioCompact II

The BioCompact ll design is a general–purpose cabinet that features a forced air distribution system. BioCompact ll cabinets feature the same high– specification control system as the BioMidi model. BioCompact ll cabinets are available in sizes from full–height to under–counter models.

BIOCOMPACT II

Scoping GMP

GMP requirements and instructions are not definitive or exhaustive on how to manufacture specific medicines or medical devices. But it does outline how storage conditions should be controlled and monitored.

 

Eudralex volume 4 annex 1 chapter 3

Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits.  Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.

  • Features enabling the use of Gram BioLine cabinets in GMP environments: Forced air distribution, IQ,OQ,PQ documents, access port for accurate and unobtrusive validation, advanced controller with calibration function.