BAGS FOR MEDICAL AND PHARMACEUTICAL APPLICATIONS
Customization
From Feasibility Studies to the Design and Realization of Customized Solutions
Haemopharm's know-how and highly professional team enable it to come up with the best solutions for specific applications.
1. Feasibility and Requirements Analyses:
We analyse requirements according to the therapeutic needs, looking for possible solutions both with already existing production processes and by doing research into processes and innovative products.
2. Procedure Checking:
We assess if existing techniques or new ones are needed to satisfy the requirements.
3. Design and Research for Special Solutions:
We design unique systems that are in step with therapeutic, legislative, normative and market innovations.
4. Design and Realization of Moulds:
In-house design and production of the moulds and tooling enables Haemopharm to significantly reduce its idea concept to production times and guarantee both maximum product quality and the minimum production costs.
5. Prototyping
We offer a prototyping service to guarantee the functionality and quality of requested products. The professionalism and experience of Haemopharm's specialists ensure the correct choice in raw materials and processes to meet requested applications.
6. Assistance in Experimentation:
Haemopharm is also at your service for technical, clinical and other types of experimentation and research.
7. Clean Rooms:
All production and analytical phases are carried out in more than 1,600 squre 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 (Even in Small Quantities):
We run pilot productions on demand, and even in small quantities in the case of technical, clinical or market testing. Fast delivery times are ensured.
9. Printing and Packaging:
The printing of text on the bags takes place by way of the 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 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.
Most importantly, Haemopharm customers routinely verify our commitment to quality and standards complicance with on site audits.
13. Dossier Backup:
For your specific products, Haemopharm regulatory affairs also provides the service of writing dossiers for Drug Master Files in CRT format and Technical Files for medical devices bearing the CE mark.
The professional team at Haemopharm is committed to providing products and services that meet your needs and places significant emphasis in a combination of three factors: high product quality with on time deliveries at competitive market pricing.
contact us for information and estimates.
A collection of samples of various products is readily available.
Haemopharm's know-how and highly professional team enable it to come up with the best solutions for specific applications.
1. Feasibility and Requirements Analyses:
We analyse requirements according to the therapeutic needs, looking for possible solutions both with already existing production processes and by doing research into processes and innovative products.
2. Procedure Checking:
We assess if existing techniques or new ones are needed to satisfy the requirements.
3. Design and Research for Special Solutions:
We design unique systems that are in step with therapeutic, legislative, normative and market innovations.
4. Design and Realization of Moulds: In-house design and production of the moulds and tooling enables Haemopharm to significantly reduce its idea concept to production times and guarantee both maximum product quality and the minimum production costs.
5. Prototyping
We offer a prototyping service to guarantee the functionality and quality of requested products. The professionalism and experience of Haemopharm's specialists ensure the correct choice in raw materials and processes to meet requested applications.
6. Assistance in Experimentation:
Haemopharm is also at your service for technical, clinical and other types of experimentation and research.
7. Clean Rooms:All production and analytical phases are carried out in more than 1,600 squre 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 (Even in Small Quantities):
We run pilot productions on demand, and even in small quantities in the case of technical, clinical or market testing. Fast delivery times are ensured.
9. Printing and Packaging:
The printing of text on the bags takes place by way of the 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 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.
Most importantly, Haemopharm customers routinely verify our commitment to quality and standards complicance with on site audits.
13. Dossier Backup:
For your specific products, Haemopharm regulatory affairs also provides the service of writing dossiers for Drug Master Files in CRT format and Technical Files for medical devices bearing the CE mark.
The professional team at Haemopharm is committed to providing products and services that meet your needs and places significant emphasis in a combination of three factors: high product quality with on time deliveries at competitive market pricing.
contact us for information and estimates.
A collection of samples of various products is readily available.