bene – over 40 years experience in suppository production

The name bene stands for almost half a century of expertise in the field of suppository production. During this period we have manufactured over 1,000,000,000 suppositories.

Production takes place using modern Sarong SAAS 15 AP lines with a maximum output of 60,000 suppositories per hour, plus connected cartoners (Bosch CUT, IMA Flexa).

The primary packaging consists of aluminium foil or PVC film.

Safety is guaranteed by:

• Patient Information Leaflet feed from the roll,
  
• thus preventing errors
• Barcode reader for 100 per cent identity checks of printed packaging: primary packaging, pack leaflet, folding box
• Luminescence detectors for 100 per cent checks on presence of Patient Information Leaflet
• Belt scales at end of line for 100 per cent pack weight check
  

Tablet production

an IMA C 80/A81 (max. 400 blister packs per minute).

Safety is guaranteed by:

• Fully automatic in-process controls of tablet mass,
  base height and hardness
• Patient Information Leaflet feed from the roll,
  thus preventing errors
• Barcode reader for 100 per cent identity checks of printed packaging: primary packaging, pack leaflet, folding box
• Luminescence detectors for 100 per cent checks on presence of Patient Information Leaflett
• Belt scales at end of line for 100 per cent pack weight check

Liquid production

• Clearance analysis according to either the Pharmacopoeia (Arzneibuch) or client-specific requirements
• Method development and validation according to ICH guidelines
• Stability management; planning and execution of stability testing, evaluation and reporting. We operate our own climatic hambers meeting ICH conditions for long-term stability testing and stress testing.
  
• Support with and execution of process validation and purity validation testing.
• As part of our full service we also prepare operating instructions, test regulations, plans and reports.
• Specifically for the investigation of water in accordance with the Pharmacopoeia we offer the TOC parameter plus comprehensive assistance.
  

Here is a selection of the modern analysis equipment

at our disposal:

• Gas chromatograph with FID
• Several HPLC, UV and diode array detectors
• Ion chromatograph
• Photometer
• Infrared spectrometer (FTIR)
• Total organic carbon (TOC) analyser
• Microscope with digital image processing
• All devices feature data capture software
• Titrators (including Karl Fischer [titrators])
• Various pharmaceutical-specific standard testing devices,
  for instance for determining disintegration times, active ingredient release or the resistance to breaking of suppositories