Fill & Finish

All of our production takes place on site and under one roof from a single provider.

Pharmpur specia­lizes in producing liquid medicinal and medical products in syringes and vials. The production usually comprises the following steps:

  • Compo­unding
  • Filling
  • Labelling
  • Secondary Packaging
  • Steri­liz­ation
  • Final Packaging

Specia­liz­ation

The Fill & Finish processes making highly-viscous media is one of Pharmpur’s specialties. It comprises the production of homoge­neous prepa­ra­tions, low-loss product handling, and an air bubble-free filling in syringes by filling and closure processes occurring under a vacuum.

Clinical Samples

Pharmpur possesses a manufac­turing licence for the production of small-volume inves­ti­ga­tional medicinal products that are steri­lised in final containers and intended for human use in liquid form. This comprises entire or partial production entailing various related processes such as packing and labelling.

Research & Develo­pment

Pharmpur conducts research and develo­pment to synthesise new materials, bond known substances to substrate materials and produce supple­mentary and new materials for medical use which primarily comprises the hydrogel class of substances. These proce­dures include tailor-made purifi­cation processes. The projects are self-financed, as a commission order or within the framework of funded research colla­bo­ra­tions.

Innova­tions

Innovative concepts are realised via inter­di­sci­plinary colla­bo­ra­tions and brought to product maturity. Examples thereof are currently-sponsored projects. A highly motivated team of staff members with outstanding profes­sional quali­fi­ca­tions – including six PhD chemists – guarantee pragmatic and rapid completion of projects.

Finalised Funding Projects:

  • Develo­pment of perfluo­ro­al­kyl­al­kanes (project management: AiF)
  • Decubitus prophy­laxis via trans­dermal oxygen supply (project management: AiF)
  • Functional fluorides (EU project FUNFLUOS)

Magic Eye:

Laser for cataract surgery; project management: VDI. A current project in coope­ration with

  • LifePho­tonic GmbH
  • BYTEC Medizin­technik GmbH
  • Fiberware General­un­ter­nehmen für Nachrich­ten­technik GmbH
  • University Eye Hospital, Tübingen
  • Institut für Laser­tech­no­logien in der Medizin und Messtechnik Univer­sität Ulm (ILM)

Safe Light:

LED for ocular illumi­nation; project management: AiF. A current project in coope­ration with:

  • JWGU Frankfurt
  • HS Ulm
  • EPIGAP Optronic GmbH

Idea Finding

We determine the need for new products by active consul­tation with their users. Novel concepts emerge by seeking solutions to problems – and these ideas eventually lead to jointly-created project proposals.

Business Develo­pment Phase

If the proto­types satisfy the project’s specific requi­re­ments, the samples are subjected to testing in the market. The subse­quent procedure depends closely on the dialogue with users and consi­de­ration of proposals for impro­ve­ments.

Market Readiness

While waiting for product approval, distri­bution paths are identified through business networks and in close contact with opinion leaders in the industry before deciding on the ultimate version of the product.

Synthesis & Purifi­cation

The synthesis and purifi­cation of raw materials for the Fill & Finish processes are imple­mented in our own labora­tories on the kilo scale. Purifi­cation is tailored to the impurity profile resulting from the production process. The success of synthesis and purifi­cation is conti­nuously monitored by multiple specific analyses.

Analytics

The Analytics business unit is integrated within the branches of quality control, stability testing, product care, and research and develo­pment.

Quality Control

With a dense network of controls, our production processes are monitored in each batch. Within the course of the batch release, the specified values are charac­te­rized. The results are summa­rized in certi­fi­cates of analysis. These works are carried out in our in-house labora­tories by highly qualified staff members.

Specia­liz­ation

Pharmpur specia­lises in the compre­hensive production of ocular endotam­po­nades and ophthal­mo­lo­gical prepa­ra­tions with focus on silicone materials, fluor­or­ganic compounds and visco­elastic substances. All analytic methods are backed by valida­tions and are guaranteed GMP-compliant.

Chroma­to­graphic Methods

  • HPLC
  • GC/MS
  • Headspace/GC/MS
  • GPC

Physical-Chemical Processes

  • FT-IR/ATR
  • UV/VIS
  • Rheometry
  • Karl-Fischer-Titration
  • Surface tensions / inter­facial tensions
  • Specific conduc­tivity

Pharma­co­poeial Processes

  • Provi­sions of Ph. Eur.
  • Provi­sions according to USP
  • Examples:
    • pH
    • Acid content
    • Osmolality