Sterile products

All medicines and medical products to be injected have to be manufactured under sterile or aseptic conditions.

We manufacture medicines and medical products according to GMP for sterile and aseptic manufacture:

Sterile manufacture

Sterile manufacture entails a product being filled in its primary packaging, such as a vial or an ampoule, and then undergoing sterilisation. Sterile manufacture is the method EMA prescribes as the first choice. Our final sterilisation is done under high temperature and steam in an autoclave.

Products that are not temperature-sensitive are usually manufactured under sterile conditions. Sterile manufacture is the method EMA prescribes as the first choice.

We can fill a sterile product into the following packaging:

• Ampoules
• Vials
• Bottles
• Tubes

Aseptic manufacture

Aseptic manufacture entails maintaining the sterility of all components used during manufacture. All raw materials and primary packaging are thus sterilised before the mixture and filling are carried out.

In most cases, we sterile filter the finished mixed product ahead of filling. We have established procedures for sterile filtering through several different types and sizes of filters. If the filter needed for sterile filtration of your product is not part of our standard range, we can evaluate and implement a
new filter type and size ahead of your manufacture.

Products that require aseptic manufacture are:

1. Proteins and other temperature-sensitive
medicines and medical products

2. Products filled into primary packaging made from
plastic and not glass

We can fill an aseptic product into the following packaging:

• Pre-filled syringes
• Ampoules
• Vials
• Bottles
• Bags
• Eyedrop bottles
• Tubes

All sterile and aseptically filled products are put through a standard sterility test in our QC laboratory. Only when these results have been received may a QP (Qualified Person) release a product onto the market or to a clinical trial.