1. Catalogs
  2. HEXONIC CZ s.r.o.
  3. P-line Heat Exchangers in the Pharmaceutical Industry

P-line Heat Exchangers in the Pharmaceutical Industry

P-line Heat Exchangers in the Pharmaceutical Industry
1 / 11 PagesView full catalog

P-line Heat Exchangers in the Pharmaceutical Industry

Product catalog summary
Overview: The document focuses on the application of P-line heat exchangers in the pharmaceutical industry, specifically for Water for Injection (WFI) systems. It highlights the necessity of adhering to stringent hygiene standards to avoid contamination.
Specifications: P-line heat exchangers are engineered to meet top hygiene standards, conforming to PED, ASME, 3-A Sanitary Standards, and cGMP (FDA). They are made from stainless steel 316L with electropolished surfaces to reduce contamination risks.
Applications: These heat exchangers are utilized in various pharmaceutical processes, including the production of injectable and inhalation drugs, advanced therapy medicinal products, ophthalmic drugs, biotechnological preparations, and diagnostic preparations. They are also employed in cleaning containers and installations.
WFI Systems: The document describes the WFI generation process via thermal distillation, using distillation columns for evaporation and condensation. P-line heat exchangers are integral for preheating, regenerative heating, and cooling in WFI generators.
Storage and Distribution: WFI can be stored and distributed using cold or hot systems. Cold systems incorporate two heat exchangers for cooling and periodic heating for sterilization, whereas hot systems maintain a constant high temperature with steam or hot water.
Technical Parameters: Detailed technical specifications are provided, including dimensions, flow types, and connection types for various P-line heat exchanger models. Working parameters such as maximum pressure and temperature ranges are also listed.
Construction Features: P-line heat exchangers are designed with a double tube sheet to minimize cross-contamination risks. They utilize certified silicone or Viton gaskets and triclamp connections that comply with 3-A and FDA standards.
See more

Catalog excerpts

P-line Heat Exchangers in the Pharmaceutical Industry-1

P-LINE Heat Exchangers in the Pharmaceutical Industry

 Open the catalog to page 1
P-line Heat Exchangers in the Pharmaceutical Industry-2

Heat Exchangers in the Pharmaceutical Industry Generation, storage, and distribution of WFI takes place in carefully designed systems. The required work parameters Water is the most commonly used raw material in the Water for injection (WFI) is produced from purified water pharmaceutical industry. Used not only as the main that has been treated to eliminate substances harmful to the ingredient in the production of medicines and vaccines, it human body. In the production of medicines it plays the role is also utilized for cleaning technological lines and rinsing extremely important. The WFI systems...

 Open the catalog to page 2
P-line Heat Exchangers in the Pharmaceutical Industry-3

Heat exchangers in WFI generators Thermal distillation is the most common method used to obtain water for injection (WFI). WFI generator consists Production of injectable drugs Production of high purity inhalation drugs exchangers are used in the WFI generators for preheating, of one or more distillation columns in which the process • the microbiological purity of the WFI water. P-line heat regenerative heating, as well as for final condensation of of repeated evaporation and condensation of purified pure steam and cooling of generated water for injection. Production of advanced therapy medicinal...

 Open the catalog to page 3
P-line Heat Exchangers in the Pharmaceutical Industry-4

WFI cold storage and distribution system WFI hot storage and distribution system The distilled water generated must be properly stored and distributed to the points of use. Another option is the system with only one In the cold water storage and distribution system, two P-line P-line exchanger installed. It then performs heat exchangers are installed. The first one is designed to Another method of storage and distribution is by keeping the water at a constant high both functions. Depending on whether cold keep the water temperature low (at 15-30˚C) and cool the water or technical steam flows...

 Open the catalog to page 4
P-line Heat Exchangers in the Pharmaceutical Industry-5

In order to use WFI it must be cooled to the application temperature, which is usually 25°C to 45°C. If there are many points of use with the same temperature required, an additional circuit may be separated in the Another option is to place a heat exchanger just in front of the point of use (POU). system in which the P-line heat exchanger is installed. Its task is to cool the water to the application temperature. COLD WATER Figure 5. Diagram of the point of use (POU) with the P-line exchanger installed

 Open the catalog to page 5
P-line Heat Exchangers in the Pharmaceutical Industry-6

Characteristics of the P-line heat exchangers Application of P-line heat exchangers P-line heat exchangers meet the highest requirements of the pharmaceutical industry. At the same time, they meet its stringent hygiene standards imposed by inspection bodies. They have been designed to minimize the risk of contamination and to ensure safe and sterile work. Pharmaceutical industry • Clean steam generation WFI storage and distribution systems • Shell side – water, steam, other consulted with the manufacturer • Food industry Dairy industry Brewing industry CERTIFICATES AND STANDARDS Manufactured...

 Open the catalog to page 6
P-line Heat Exchangers in the Pharmaceutical Industry-7

Construction of the P-line heat exchanger Tubes are connected to the tube sheets with pressure expanding method in which clean water under pressure up to 6000 bar is used. This eliminates the risk of damaging the internal surface of the tubes. Compensator Stainless straight tubes with a diameter of 8 mm (0.315 inch) or 12,7 mm (0.5 inch). Double tube sheet reduces the risk of media cross-contamination. Expanded tubes are then welded to the external tube sheet with orbital using welding a pure argon shield method. Certified silicone or Viton gaskets and triclamps, the clean side connections, in...

 Open the catalog to page 7
P-line Heat Exchangers in the Pharmaceutical Industry-8

Dimensions of P-line heat exchangers Technical parameters Dimensions Type Standard location of connections: K4 / K1 – inlet /outlet tube side (hygienic side) K2 / K3 –inlet /outlet shell side WORKING PARAMETERS Gaskets Technical drawing (service side) Position options Flow types *Parameters for P-050: max. temp. (Silicone) 140°C (284°F), min. temp. (Viton) -25 °C (-13 °F). All dimensions and technical data are approximate only and may be changed without further

 Open the catalog to page 8
P-line Heat Exchangers in the Pharmaceutical Industry-9

Tube diameter Heat exchange area Tube side capacity TYPE 4P Connection type and material FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676 Type A, SS FLANGE EN 1092-1 PN16 01B, TRI-CLAMP DIN 32676...

 Open the catalog to page 9
P-line Heat Exchangers in the Pharmaceutical Industry-10

P-line heat exchangers can be installed vertically or horizontally depending on the application and available space. Exemplar designation 4P - czteroprzepływowy poziomej Montaż w pozycji Montaż w pozycji pionowej Montaż w pozycji poziomej 1P - jednoprzepływowy Montaż w pozycji pionowej 1P – jednoprzepływowy 2P and 4P heat exchanger Montaż w pozycji pionowej Montaż w pozycji poziomej Montaż w pozycji pionowej Montaż w pozycji poziomej Montaż w pozycji pionowej 1P - jednoprzepływowy1P – jednoprzepływowy 2P Vertical mounting Montaż w pozycji pionowej 1P – jednoprzepływowy heat exchanger type shell...

 Open the catalog to page 10

All HEXONIC CZ s.r.o. catalogs and technical brochures

  1. CIP

    13  Pages

  2. JAG SHIELD

    7  Pages

  3. JAD

    13  Pages

  4. DNA

    5  Pages

  5. LA21AS

    5  Pages

Archived catalogs

  1. Industrial

    7  Pages

  2. Oil Coolers

    11  Pages

  3. ST

    3  Pages

  4. JAD 2021

    15  Pages

  5. Dry cooler

    11  Pages

  6. DNA ECO

    1  Page

  7. Custom

    3  Pages

  8. HAD 2020

    3  Pages

  9. JAD 2020

    3  Pages

  10. P-line

    3  Pages

  11. PHE

    3  Pages

  12. Luna

    3  Pages

  13. Safe plate

    3  Pages

  14. R-line

    3  Pages

  15. L-line

    3  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.