Research & Development

The opinion leaders in the Medical Science field are a point of reference for Haemopharm, that dedicates a significant amount of resources to the financing of research and development, mostly aimed at the design of delivery systems with advanced functions, complex biomedical devices, suited for the preservation and manipulation of drugs of various types, but also sensitive biologics, such as cells, tissues and organs.
In particular, R&D activities are mainly oriented on three focuses:

Design of new products

The development starts from the study of the therapeutic needs of the users to whom they are intended, with the aim of proposing innovative solutions capable of solving the most frequent problems and opening up new application possibilities.

Innovative and highly performing materials

The company is able to offer cutting-edge materials of the highest quality (in terms of container-content interaction, barrier properties, etc …) suitable for the production of bags and components for the pharmaceutical and medical sector, studying the most suitable solution for specific to each project, to ensure the best preservation and stability of the drug.

Implementation of machines for the production of PVC and PVC-free bags and related molds

Thanks to a high-profile engineering know-how and a large and well-equipped internal workshop, Haemopharm is able to manage the entire production cycle, from the construction of customized machines and molds, to the creation of protypes up to the production of finished products.

IN Contract Manufacturing: standard or “tailor made” solutions

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, providing companies in the medical and pharmaceutical sector a production organization and capacity with the plus of flexibility.
In response to specific needs, Hameopharm is able to design and deliver “tailor-made” products taking advantages of an efficient Just-In-Time Production.
The ability to manage all production processes as a single supplier for the customer, from the feasibility study, to the realization of the molds up to the sterilization procedures, allows to carry out prototypes and tailor-made productions, guaranteeing excellent quality, in reduced times and a competitive price.

1. Feasibility and Requirement Analysis

2. Procedure Check

3. Design and Research for Special Solutions

4. Design and Realization of Moulds

5. Prototyping

6. Testing service and assistance

7. Custom-Made Production (Also for Small Quantities)

8. Sterilization and Validation

9. Printing and Packaging

10. Dossier creation support


OUT Contract Manufacturing: a global network of partners

Another Haemophorm’s key area of expertise is represented by the “pharma outsourcing”: filling its own bags taking advantage of the service of “OUT” Contract Manufacturing. Haemophorm has developed a range of Partnerships with global pharmaceutical companies (mostly FDA approved) that for many years fill the empty bogs manufactured by Haemopharm with different types of sterile liquids.
A specialized division manages and controls the processes of “pharma outsourcing” so that Haemopharm con obtain:

  • High quality
  • High level of customization
  • Local Marketing Authorizations on the finished product
  • Choice of the most suitable product (small volumes, big volumes, multi-chamber bags, etc…)
  • Low production costs
  • Low logistic and transport costs

Asepting Filling

The expansion of the Haemopharm Factory, started in 2015, allowed the set up of a Compounding Deportment fully dedicated to aseptic production of sterile fluids (mainly preservation liquids for the containment of cells, tissues and organs and small volume custom-made solutions).
The Compounding Department includes on aseptic filling area, equipped with an isolator specifically designed to maintain an aseptic environment throughout the compounding and material transfer processes, and a technological laboratory equipped with advanced instrumentation.

The most stringent levels of environment control are applied

During the aseptic processing, device containers and closures are first subjected to validated sterilization by a terminal method and the sterility of the device is achieved by filtering bulk solution through a bacteria retaining filter into the final sterile product containers.

System and Quality Control

All Haemopharm products are CE marked, since safety is an essential value for the company. Moreover, the company daily gives its full attention to efficacy and quality of its production processes: the parameters of every system are constantly monitored by the proprietary software system for quality control, and all the procedures are UNI CEI EN ISO 13485:2016 and UNI EN ISO 9001:2015 certified.
Finally, the productive and analytical stages take place in a Clean Room and controlled environment in many classifications, in compliance with cGMP and with UNI EN ISO 14644-1-2-3-4-5-6-7 procedures, and are constantly verified with Audit Methods.

Advanced line monitoring systems

Haemophorm implemented o pioneering parametric and online camera control that allows the 100% inspection of the products.
The proprietary software, dedicated to the monitoring of the process and all the production steps, guarantees a top level product quality.

Quality Certifications

2012

UNI EN ISO 9001:2008 for the following products/services:

Design and production of empty bags for parenteral, enteral nutrition and for cryopreservation. Production of empty bags for infusion solution and dialysis on customer specification. Design and manufacture of disposable devices and components for infusion and transfusion. Design and production of solutions for renal therapies, sterile wash solutions and for set for major auto-hemo infusion with ozone.

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UNI EN ISO 9001:2008 for the following products/services:

Design and production of empty bags for parenteral, enteral nutrition and for cryopreservation. Production of empty bags for infusion solution and dialysis on customer specification. Design and manufacture of disposable devices and components for infusion and transfusion. Design and production of solutions for renal therapies, sterile wash solutions and for set for major auto-hemo infusion with ozone.

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2015
2016

UNI CEI EN ISO 13485:2003 for the following products/services:

Design and production of empty bags for cryopreservation, enteral/parenteral nutrition, collection and drainage; of medical devices for infusion and transfusion and set for auto-haemo infusione with ozone. Design and production of solutions for dialysis, irrigation, washing and instillation therapy. Production on specific of the customer of empty bags for infusion and/or dialysis.

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UNI EN ISO 9001:2015 for the following products/services:

Design and manufacturing of empty bags for cryoconservation, enteral/parenteral nutrition, collecting and drainage, of medical devices for infusion and transfusionnof ozone large autohaemoinfusion sets. Design and manufacturing of solutions for renal therapies, for irrigation, for washing and instillation. Manufacturing of empty infusion or dialysis bags under customers specifications.

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UNI CEI EN ISO 13485:2016 for the following products/services:

Design and manufacturing of empty bags for cryoconservation, enteral/parenteral nutrition, collecting and drainage, of medical devices for infusion and transfusion of ozone large autohaemoinfusion sets. Design and manufacturing of solutions for renal therapies, for irrigation, for washing and instillation. Manufacturing of empty infusion or dialysis bags under customers specifications.

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2018

CE marks, FDA DMF & other Marketing Authorizations

2004

CE MARK of “NUTRILINE, sterile bag for parenteral and enteral nutrition”.

CE MARK of “PERILINE®, patient set for peritoneal dialysis”.


CE MARK of “COMBYLINE, HAEMOLINE, FLOWLINE, UROLINE, medical devices for infusion and transfusion, sterile”.


CE MARK of “UROFLUSH, solution G and UROFLUSH solution R”.


CE MARK of “SAFE2®, bags for cryopreservation of stem cells”.


CE MARK of “SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile”.


CE MARK of “SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile”.


CE MARK of “FILLCHOICE®, bag with sterile solutions for washing, irrigation and instillation”.


CE MARK of “Sterile and apyrogenic solutions for washing and irrigation”.


CE MARK of “Solutions for continuous renal replacement therapy, sterile”.


CE MARK of “WASHOUT, bag with sterile solutions for washing and irrigation”.


CE MARK of “CITRACHOICE, sterile solution for CRRT”.


CE MARK of “MIXSOL, sterile solution for continuous renal replacement therapies”.


2005
2008

CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.

CE MARK of “Solutions for continuous replacement dialysis therapies”

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CE MARK of “Medical infusion and transfusion devices, sterile: COMBYLine, IV set for infusion, sterile – HAEMOline, IV set for transfusion, sterile – FLOWLine, IV set for infusion with flow regulator, sterile – UROLine, IV set for urological irrigation, sterile”

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CE MARK of “Disposable for APD, sterile”.


CE MARK of “Collection bags, sterile”.

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CE MARK of “SAFE2®, bags for cryopreservation of stem cells”.

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CE MARK of “NUTRILINE, empty bags for parenteral/enteral nutrition and PERILINE, patient connection set”.

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2009
2010

COLOMBIAN REGISTRATION INVIMA of “NUTRILINE, sterile bag for parenteral and enteral nutrition”.

CE MARK of “BREATHCHOICE, double bag for lactose intolerance breath test”.


RUSSIAN REGISTRATION of “Polyolefin bags, injection point, vial stopper”.

2005
2012

CE MARK of “Sterile solutions for continuous renal replacement therapies; CITRACHOICE, sterile; MIXSOL, sterile”

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CE MARK of “FILLCHOICE, with sterile and pyrogen free solutions for washing, instillation and irrigation”.

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FDA Device Master File n.27342 of “Plastic bags for pharmaceutical solution and their components”.


CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.

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2013
2014

CE MARK of “INFUSIONCOLOGY®, infusion sets designed specifically for oncology”.


CE MARK of “SAFE2®, bags for cryopreservation of stem cells – SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile – SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile”.

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CE MARKS of “Non-active devices for injection, infusion, transfusion and dialysis, sterile; Non-active disponsable device, sterile: FILLCHOICE® bag with sterile solutions for washing, irrigation and instillation – Sterile and apyrogenic solutions for washing and irrigation – UROFlush solutio G – Uroflush solutio R – WASHOUT bag with sterile solutions for washing and irrigation – Disposable per APD, sterile – COMBYLine, IV set for infusion, sterile – HAEMOline, IV set for transfusion, sterile – FLOWLine, IV set for infusion with flow regulator, sterile – UROLine, IV set and accessories for urological irrigation, sterile – INFUSIONCOLOGY, infusion sets designed specifically for oncology – SANO3, set for auto hemo-infusion with ozone, sterile – SAFE2®, bags for cryopreservation of stem cells”. SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile – SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile – CITRACHOICE, sterile solution for CRRT – Mixsol, sterile solution for CRRT – Haemobic, sterile solution for CRRT”.

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CE MARK of “Sterile solutions for continuous renal replacement therapies:CITRACHOICE, sterile; MIXSOL, sterile”.

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CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.

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CE MARK of “Non-active disponsable devices, sterile: NUTRILINE, empty bags for parenteral/enteral nutrition; PERILINE, patient connection set; Empty collection bags; ADIPOCHOICE®, bags for cryopreservation of tissues, sterile”.

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2015
2017

FDA Device Master III File n.27342 of “Plastic bags for pharmaceutical solutions and their components”.

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CE MARK of “Liquid for the preservation of corneal graft in hypothermic conditions up to 14 days, sterile: iRESTORE Conservation, sterile”.

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