The Process

From Feasibility Studies to the Design and Realization of Customized Solutions.
Haemopharm's know-how and highly professional team enable the company to find the best solutions for specific applications.

1. Feasibility and Requirement Analysis:
We analyse requirements according to the therapeutic needs, searching for possible solutions with already existing production processes, as well as searching for innovative solutions and products.

2. Procedure Check:
We assess if existing techniques or new ones are needed, in order to satisfy the product and customer requirements.

3. Design and Research for Special Solutions:
We design unique systems in order to meet with therapeutic, legislative and market requirements and innovations.

4. Design and Realization of Moulds:
In-house design and production of the moulds and tooling significantly reduce production times and guarantee both maximum product quality and minimum production costs.


5. Prototyping:
We offer a prototyping service in order to guarantee the functionality and quality of requested products. The competence and experience of Haemopharm's specialists ensure the correct choice of raw materials and processes which assure compatibility to the requested applications.

6. Testing service and assistance:
Services of technical, clinical and other types of testing and research are available.

7. Clean Rooms:
All production and analytical phases are performed in an area of a 600 square meters of clean rooms and controlled adjoining rooms of various classifications according to ISO 14644 - 1-2-3-4-5-6-7.

8. Custom-Made Production (Also for Small Quantities):
We run pilot productions on demand, also for small quantities in the case of technical, clinical or market testing.

9. Printing and Packaging:
The printing of text on the bags is performed through thermal transfer of inert pigments available in various colours. Labelling is also available according to client specifications. Haemopharm provides a wide range of packaging and packing solutions, from bulk deliveries of non-sterile products to individual sterile secondary packs.


10. Bag Filling:
Bags can be filled with different types of solutions which are produced within cleanrooms and according to cGMP (Current Good Manufacturing Practice).

11. Sterilization and Validation:
Haemopharm has validated the ETO sterilization processes, gamma ray processes and steam processes in conformity with the requirements of current international regulations for medical devices and pharmaceuticals.

12. Procedure Certification and Quality Assurance:
Procedures are certified according to UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 standards and are carried out in compliance with cGMP certification. Haemopharm customers periodically verify our commitment to quality and standards compliance with on site audits.

13. Dossier creation support:
For required products, Haemopharm's Regulatory team also provides Dossier creation services for Drug Master Files in CRT format and Technical Files for CE marked medical devices.

 

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