Technical Details of Ampoules for Valuable Drugs

With an increasing focus on costs in the healthcare sector, the quick and simple processing of primary packaging containers is key to optimizing the total cost of ownership. SCHOTT ampoules undergo stringent quality-control checks and have excellent properties to ensure that valuable drugs remain stable.

SCHOTT ampoules – dedicated to superior performance

Excellent fill + finish

SCHOTT ampoules have an 100% controlled dimensional quality, which results in fast and reliable filling and closing of the ampoules, as well as constant camera inspection to avoid the amount of rejects. We also offer technical support for ampoule processing, such as burner settings.

Quality-controlled production

Automated, environmentally controlled facilities, which are ISO 9001 and ISO 15378 certified, run a rigorous 12-step production process. Ampoules are inspected three times – twice with cameras and once manually – to ensure cosmetic integrity, compliance with specified dimensions, and efficient functionality.

Outstanding stability

SCHOTT ampoules are 100% glass, so preserve the effectiveness and stability of medicines with their superior barrier properties, tamper-proof design and solid extractables and leachables profiles.

Easy handling and opening

Flexibility of openings is guaranteed, with a useful variety of different break systems available, such as One Point Cut (OPC), Scoring (SCO), Color Break Ring (CBR).

Dimensions and Cosmetics

For an outstanding processability, SCHOTT provides tight geometric tolerances thanks to 100% camera inspection for tubing and containers. Low cosmetic defect levels are a result of cosmetic defect detection during the tube drawing process and an avoidance of glass-to-glass contact during container forming. 

A broad range of ampoule sizes enable us to tailor the primary packaging solution to your specific requirement.

 Dimensions and Cosmetics  

Printing options

  • Multiple identification rings
  • Text or logos
  • Authentication features

Dimensions and Cosmetics

Dimensions and Cosmetics

Form and Nominal Volume

The opening form of an ampoule is determined by the filling equipment. SCHOTT ampoules forms follow your filling equipment needs that process millions of glass ampoules every day. In general they can be distinguished as:

  • Open ampoules with form B and C (1-30 ml)
  • Closed ampoules with D (1-30 ml)
  • SCHOTT ampoules – Marzocchi (1-20 ml)
Ampoules_Comparison_WEB_936x524px
   

 

Hydrolytic Resistance

Reduced alkalinity is a challenge when it comes to the storage of water for injection or sensitive drugs, since pH shift can occur and disturb the drug stability over its shelf-life. SCHOTT provides the answer in the form of FIOLAX® CHR (Controlled Hydrolitic Resistance), which fullfills and complies with PH.Eur., USP and JP international standards.

Strength

Every day, worldwide, millions of glass ampoules are used for injectable drugs. The opening of an ampoule is ultimately a controlled glass breakage and one of the main challenges for healthcare professionals. We offer all type of break systems following ISO breaking force range or tighter:

 
  • OPC One Point Cut + easyOPC
  • CBR Color Break Ring
  • SCO Scoring
 Strength

Mechanical

Glide Finish is an outer surface treatment intended to solve the climbing and sticking effect during processing. This is applied after the annealing step. We recommend simple brushing.

Mechanical

Material / Glass Type

SCHOTT ampoules are produced using a choice of glass materials, each with their own individual properties for specific applications. These materials include: 

  • FIOLAX® clear and amber
  • FIOLAX® (CHR) clear
  • BORO-8330TM
  • ILLAX®

Want to know more? Let's talk

Whether you need more information, samples, a quote, or advice for a project, I would be delighted to talk to you.

Contact us
Victoria de la Torre - Graduate Global Product Management
Victoria de la Torre

Graduate Global Product Management