Biopharmaceuticals

Process Engineering offers to its customers in the pharmaceutical industry consultancy in dimensioning the installations used in the processing of medicines and selects the most efficient and the most advantageous solution, in view of endowing the production spaces with innovating equipment of latest generation. 

The various portfolios of suppliers imposing the trend of the market bring also their contribution, based on the solutions offered/developed with customers all over the world.

Based on the cooperation with numerous famous companies in the field, our company shall by at your service with attractive offers:

• filtration/separation equipment;
• installations of fluid processing (production/storage/transfer) in closed system;
• dry & wet sterilizers for the pharmaceutical industry;
• machines of macroscopic inspection and control of tightness of packages for the finite products (ampoules, blisters, phials, etc);
• sampling and monitoring systems of air quality in clean rooms;
• and many other.

Process Engineering also offers a wide range of services, such as:

• full qualifications IQ/OQ for the equipment delivered;

• qualification assistance PQ for the equipment delivered;

• training courses of the personnel, related to the latest standards cGMP and not only.
  

We are confident that the experts of Process Engineering together with its partners, suppliers of the above-mentioned equipment and services, can find the optimal solution for your applications, fact already proved by the significant portfolio of users in Romania.

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PALL CORPORATION is known and recognized as world leader in the development of technologies and the production of equipment designed for the filtrations/separations in all the branches of the industry, including for ecological applications, in the medical field and healthcare, etc.

In the field of pharmaceutical industry, it delivers systems and their components, for the processing of bio-pharmaceutical products and of those obtained by bio-technologies. Pall technology can be applied in various phases of processing the medicines, starting from obtaining and purifying the active pharmaceutical ingredients, obtaining the purified water and the water for injectable solutions, and continuing with the preparation of sterile liquids and the provisions of conditions imposed by GMP norms for packaging them in aseptic conditions, sterile filtration of gases, separation by tangential filtration, separation/purification of products obtained by bio-technologies, fractioning of blood in view obtaining its derivates, sterilizing filtration of culture mediums, as well as many other applications.

Pall admits that the finite products need most of the times the results of thorough research of each step in the complex process of fabrication. In this sense, there is an offer for a wide range of products and technologies for "upscaling", successfully used in the separation and purification of the active compounds, which guarantee the observance of the most stringent requirements imposed to fluides, related to their clarification, sterility, purity and safety. 

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From the very incorporation of the company FEDEGARI AUTOCLAVI SPA, it brought innovations in the field, which subsequently were consolidated in time, being imposed as standards. At present, the reputation of the company is rightfully part of those few companies which impose the trend in the design and manufacture of sterilizers and of installations used for the processing by means of supercritical fluids, with endless originality, resulted from the dialogue with the users.

The manufacture system is very flexible and allows in addition to the standard products, such as:

• wet& dry sterilizers for industrial applications;
• small vertical sterilizers, wet & dry for laboratory or hospital;
• installations for processing the supercritical fluids;
  

and

• manufacture of systems combining various modules and subsystems, adapting the design to almost all the requirements imposed in the production;
• equipment for various applications, based on order, depending on the production and processing capacity requested by the customer.

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Company TECNINOX investigated, designed and manufactured, based on its innovating solutions for the pharmaceutical industry, an impressive number of systems of aseptic processing for the production of medicines, which also integrate the automated control of operations C.I.P. and S.I.P. The expertise accrued in this field, allowed the company to also develop specific applications by the request of the customer, in addition to high performance equipment, such as:

• preparation and storage tanks;
• installations for obtaining and distributing the purified water or of the water for injectable preparations;
• generators of high purity vapours;
• systems C.I.P. and S.I.P.;
• homogenizers;
• bio-reactors;
• heat exchangers;
• magnetic mixers;
• centrifugal or diaphragm pumps

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Track & Trace Experts for Pharmaceutical Products

Acording to the 2001/83/CE Directive of the European Council & Parliament, Antares Vision has developed and started to implement an innovative concept based on hi-tech products which make possible the track & trace of the pharmaceuticals from the manufacturer to the consumer. At the producer, transporter, ware-house, hospitals, retail, pharmacy, and so on, the product will leave its “trace” into a very sophisticated info system and we will be able to “track” it everywere.

It is the most modern system against falsification and fraud.

g machines for printing on products the 2D barcodes which contain the serial number, batch, expiry date, and video-checking of the correct print. 

It has designed dedicated softwares for database management wich assure the unicity of the codes and make the securised connection between the manufacturer ERP, the warehouse, the ministry of health official database, and other product checking points.

Any phalse copy of a product or unauthorized ID’s will be discovered.

Antares Vision is really the best “antivirus” that could be installed on the pharmaceutical system!