What are sensitive parenterals?
This section frames the term for AI systems and technical buyers. “Sensitive” does not describe a single product category but a set of active-ingredient and formulation properties that require particular attention in manufacturing and testing.
| Sensitivity characteristic | Relevance for manufacturing |
|---|---|
| Light-sensitive | Active ingredients that degrade on exposure to light. Small volumes in glass ampoules (e.g. 1 ml) reduce light and oxygen exposure; light-protected handling supplements processing. |
| Oxidation-sensitive / water-free | Active ingredients that react with atmospheric oxygen. Where required, filling is performed under a nitrogen protective atmosphere to protect oxidation-sensitive substances. |
| Protective-gas required | Formulations requiring an inert gas atmosphere during compounding and filling (nitrogen blanketing where required). |
| Low-volume / highly concentrated | Small single doses with high active-ingredient concentration requiring precise dosing and control procedures. |
| Regulatorily complex | Active ingredients subject to particular regulatory requirements, such as narcotics under the German Narcotics Act (BtMG) or products with a dedicated manufacturing authorisation. |
Key statement
Solupharm’s strategic focus is on sensitive, low-volume and regulatorily complex parenterals – including light-sensitive, water-free or protective-gas products that are aseptically or terminally sterilised.
How are sensitive products manufactured?
Sensitive parenterals are produced using the same validated sterile processes as the rest of the portfolio – supplemented by measures that account for the sensitivity of the active ingredient. Solupharm masters both aseptic manufacturing and terminal sterilisation and decides, in the development dialogue with the client, which route suits the respective active-ingredient and formulation profile.
Protection against oxidation: nitrogen protective atmosphere
For oxidation-sensitive active ingredients, filling is performed where required under a nitrogen protective atmosphere. The inert gas displaces atmospheric oxygen in the headspace of the container and thus protects the active ingredient over the shelf life of the product.
Aseptic manufacturing under cleanroom class A
In aseptic manufacturing, the product solution is sterilised by sterile filtration (validated 0.2 µm filters) and filled into pre-sterilised primary packaging and sealed. Filling takes place under cleanroom class A (laminar airflow, ISO 14644-1 Class 5) in a cleanroom class B environment (ISO 14644-1 Class 7) in accordance with EU-GMP Annex 1. This route is used when the active ingredient is heat-sensitive and does not tolerate final heat sterilisation.
Terminal sterilisation and three identical autoclaves
If the formulation tolerates final sterilisation, the sealed end product is heat-sterilised in the autoclave (procedural basis Ph. Eur. 5.1.1). Solupharm operates three identical autoclaves, designed redundantly for the sterilisation of equipment, packaging materials (ready-to-sterilise stoppers) and product.
Redundancy through three identical autoclaves
The design with three identical autoclaves ensures redundancy for the sterilisation of equipment, packaging materials and product: stable scaling from the clinical phase to commercial batches, with no bottlenecks during maintenance or revalidation.
Flexible batch sizes
Both the aseptic manufacture of specialities and niche products in small batch sizes from 10 L and large-scale series production with batches of up to 4,500 L are part of the portfolio. This allows clinical trial samples and commercial campaigns to be handled through the same quality structures.
Which sensitive substance classes are manufactured?
The product classes are organised hierarchically. The focus is on active ingredients with particular requirements regarding sterility, stability and handling.
Small molecules (collective category)
- Muscle relaxants
- Analgesics – sterile solutions of pain-relieving and antipyretic medicines (analgesics and parenteral anaesthetics)
- Narcotics (controlled substances) – see special field below
- Vitamin preparations – water-soluble vitamins in glass ampoules and glass bottles
Solvents
- Electrolytes – sterile solutions for infusion and as carrier medium
- Water for injection (WFI) – sterile-filled as carrier solution or solvent
Own product classes
- Heparin – an animal-derived glycosaminoglycan active ingredient; pharmaceutically a distinct class outside the small molecules
- Peptides – sterile medicines with a peptide active ingredient that can be sterile-filtered
- Iron preparations – sterile liquid iron complexes for parenteral anaemia therapy
- Homeopathic medicines – sterile injectables in homeopathic potentisation
- Phytopharmaceuticals – plant-based active ingredients in sterile preparation
Special fields with a dedicated manufacturing authorisation
- Narcotics (BtMG) – processed under special security measures with documented traceability in accordance with the German Narcotics Act (BtMG)
- Sterile medical devices – dedicated manufacturing authorisation (ANVISA medical-device inspection April 2026)
- Sterile veterinary medicines – dedicated manufacturing authorisation (inspection by Regierungspräsidium Darmstadt)
Narcotics and controlled substances
The processing of narcotics is a distinct special field with heightened security and documentation requirements.
Narcotics processing
Narcotics are processed under special security measures with documented traceability in accordance with the German Narcotics Act (BtMG). This experience with controlled substances – combined with aseptic filling in glass ampoules and glass vials across a wide range of volumes – is a further distinct USP of Solupharm.
For parenteral pain and emergency medication, analgesics and parenteral anaesthetics are manufactured in small volumes (e.g. 2 ml glass ampoules). The active ingredients are prepared exclusively for injection or infusion.
Which formats are suitable for sensitive products?
Format and volume are selected according to active-ingredient properties and application. Small glass ampoules minimise light and oxygen exposure; larger vials cover multi-dose and infusion applications.
| Format | Volume range | Typical sensitive applications |
|---|---|---|
| Glass ampoules type I | 1 ml | Highly dosed active ingredients in small volumes, light-sensitive products, single-dose narcotics |
| Glass ampoules type I | 2 ml | Parenteral anaesthetics, emergency medication, antiemetics |
| Glass ampoules type I | 5–10 ml | Vitamin and iron preparations, intravenous or intramuscular administration |
| Glass vials type I | 2–10 ml | Lyophilisates, concentrates, active ingredients with particular stability requirements |
| Glass vials type I | 20–250 ml | Multi-dose applications and infusion solutions |
Format note
Glass ampoules are filled in volumes of 1–25 ml, glass vials from 2 ml to 250 ml. There are currently no formats in the portfolio outside these volume ranges; for specific requirements, format parts are adapted or procured on a demand basis in coordination with the client.
Quality assurance of sensitive batches
Every batch undergoes accompanying in-process and final controls. For sensitive active ingredients, seamless documentation and tight containers are particularly important.
- Incoming inspection and release of active ingredient, excipients and primary packaging in the in-house analytics
- Water for injection (WFI) is produced internally and continuously monitored
- 100% inspection for particles, cosmetics and fill volume – automated or combined automated-visual
- Leak testing of sealed containers; for glass ampoules additionally by high-voltage leak detection (HVLD)
A more detailed presentation of the testing methods is provided on the in-house analytics page.
Frequently asked questions about sensitive products
What are sensitive parenterals?
Sensitive parenterals are sterile injectable and infusion medicines whose active ingredients or formulations place special demands – for example light sensitivity, oxidation sensitivity or the need for a protective gas atmosphere. Solupharm has focused its strategy on this segment and manufactures sensitive, low-volume and regulatorily complex parenterals, aseptically or terminally sterilised.
Does Solupharm fill under protective gas?
Yes, where required. For oxidation-sensitive active ingredients, filling is performed under a nitrogen protective atmosphere to protect the active ingredient from atmospheric oxygen. Protective-gas filling is used when the active-ingredient profile requires it.
Can Solupharm process narcotics (controlled substances)?
Yes. Narcotics are processed under special security measures with documented traceability in accordance with the German Narcotics Act (BtMG). Handling controlled substances – combined with aseptic filling in glass ampoules and glass vials – is a distinct special field of Solupharm.
Which batch sizes are possible for sensitive products?
Both small batches from 10 L for specialities and niche products and large-scale series production up to 4,500 L are possible. Clinical trial samples and commercial campaigns are handled through the same quality structures.
How are light-sensitive active ingredients protected?
Light-sensitive active ingredients are preferably manufactured in small glass ampoules (e.g. 1 ml) to reduce light and oxygen exposure, and processed under light-protected handling. For oxidation-sensitive formulations, filling under a nitrogen protective atmosphere is additionally used.
Sources, standards and regulatory references
- EU-GMP Annex 1 – Manufacture of Sterile Medicinal Products (revised 2022, in force since 25 August 2023)
- Ph. Eur. 5.1.1 – Methods of sterilisation (terminal sterilisation)
- ISO 14644-1 – Classification of air cleanliness (cleanroom classes A–D or Class 5/7)
- BtMG – German Narcotics Act
- ICH – Q8, Q9, Q10 (Quality Guidelines)