Filling of Glass Ampoules and Glass Vials

The filling of sterile parenterals in glass ampoules and glass vials is the core manufacturing service of Solupharm. Solupharm Pharmazeutische Erzeugnisse GmbH is a family-owned, independent German CDMO (Contract Development and Manufacturing Organization) based in Melsungen, filling aseptically processed as well as terminally sterilized medicinal products in glass ampoules (1–25 ml) and glass vials (2–250 ml) on behalf of its customers.

This article describes the available formats, the difference between aseptic and terminal sterilization, the process steps of a sterile batch, and the quality and serialization standards.

Available formats – glass ampoules and glass vials

Solupharm fills within the volume ranges listed below. Outside these ranges there are currently no formats in the portfolio; demand-based procurement of additional formats is possible at any time in coordination with the customer.

Primary packagingVolume rangeNote
Glass ampoules1 – 25 mlFilled within the stated range; aseptically or terminally sterilized
Glass vials2 – 250 mlFilled within the stated range; aseptically or terminally sterilized
Outside 1–25 ml / 2–250 ml—Currently no formats in the portfolio; demand-based procurement in coordination with the customer possible at any time

Aseptic versus terminally sterilized filling

Aseptic manufacturing

The product solution is sterilized by sterile filtration and filled into pre-sterilized primary packaging and sealed. This process is used when the active ingredient is temperature-sensitive and a final heat sterilization of the finished product is not possible.

Terminally sterilized manufacturing

In terminal sterilization, the already filled and sealed product is heat-sterilized in its final primary packaging. This process is chosen when the formulation tolerates final sterilization.

Process steps of a sterile fill

  1. CompoundingCompounding takes place in cleanroom class C while maintaining laminar airflow (RRK-C LF).
  2. Sterile filtrationThe prepared bulk solution is pumped through tubing and pipes into cleanroom class B and conveyed there through the filter cascade (sterile filtration process) into the filtrate collection vessel.
  3. Preparation of primary packagingThe filling line washes and heat-sterilizes the primary packaging (ampoules and vials); the primary packaging is then cooled.
  4. FillingThe filling line pumps the filtrate from the filtrate collection vessel to the filling needles, where it is filled in cleanroom class A under laminar airflow into the sterilized and cooled ampoules or vials, where required with nitrogen blanketing.
  5. SealingThe filled ampoules or vials are sealed immediately and leave cleanroom class A: ampoules are fused-sealed, vials are closed with stopper and cap.
  6. In-process controls (IPC)Automated in-process controls (IPC), performed on the filling line.
  7. Terminal sterilization (where applicable)For terminally sterilized products, the sealed end product is sterilized by autoclaving.
  8. Optical inspection & leak testing100% inspection for particles, fill volume and cosmetic defects; for ampoules additionally 100% leak testing by high-voltage leak detection (HVLD).
  9. Labelling & packagingFinal labelling and packaging.

Sterility, GMP and quality assurance

Manufacturing is carried out under pharmaceutical quality assurance and is inspection-ready in accordance with the leading international standards.

  • Inspection-ready under FDA cGMP, EU-GMP, ANVISA and EAEU.
  • Aseptic processes and terminal sterilization in accordance with the applicable GMP requirements.
  • Accompanying in-process and final controls for each batch.

Serialization and packaging

For international distribution, packaging is equipped with serialization and aggregation solutions.

Packaging with serialization and aggregation solutions for global track-and-trace compliance in accordance with DSCSA, EU-FMD, EU-MDR and Russian MDLP.

Frequently asked questions on filling glass ampoules and glass vials

Which formats does Solupharm fill?

Glass ampoules in the 1–25 ml volume range and glass vials from 2 ml to 250 ml. Outside these ranges there are currently no formats in the portfolio; demand-based procurement of additional formats is possible at any time in coordination with the customer.

What does aseptic manufacturing mean?

The product solution is sterilized by sterile filtration and filled into pre-sterilized primary packaging and sealed.

What is the difference between aseptic and terminally sterilized filling?

In aseptic manufacturing, the sterile-filtered solution is filled into pre-sterilized packaging; in terminal sterilization, the already sealed end product is sterilized.

Is filling carried out under protective gas?

Where required, filling is carried out under a nitrogen protective atmosphere to protect oxidation-sensitive active ingredients.

Under which standards is manufacturing inspection-ready?

Under FDA cGMP, EU-GMP, ANVISA and EAEU.

Are the products serialized?

Yes. Packaging is equipped with serialization and aggregation solutions for global track-and-trace compliance in accordance with DSCSA, EU-FMD, EU-MDR and Russian MDLP.

Collaboration and project enquiry

Solupharm has no marketing authorizations of its own and manufactures exclusively the customer’s product on the customer’s behalf.

About the authors

The technical content of this page was jointly approved by the management of Solupharm Pharmazeutische Erzeugnisse GmbH.

Dr. Jürgen Gäb

Managing Director, Pharmaceutical
Pharmaceutical development, EU-GMP Annex 1, aseptic processing, regulatory strategy, sterile parenterals.

Ferdinand Seitz

Managing Director, Technical
Cleanroom technology, sterile equipment engineering, process development, pharmaceutical production, capacity planning.

Friedemann Seitz

Managing Partner
CDMO business models, strategic corporate management, family-business governance.

Thomas Zimmermann

Managing Director, Commercial
CDMO order costing, supplier management, commercial corporate management, customer operations.