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Pharmatec Units for the Production, Storage and Distribution of High-purity Media

High purity media units from Pharmatec

Contact Pharmatec for the planning, development and production of: High-purity steam generators Distillation units HPW generation Storage and distribution systems for high-purity water and high-purity steam
High-purity steam generators from Pharmatec can be used to produce from small to very large quantities of sterile, high-purity pyrogen-free steam. This high-purity steam is suited for: Sterilizing ttings (tanks, preparation vessels, piping systems, lling machines, lters, etc.) Humidication of air in clean rooms with WFI quality steam

Pharmaceutical products have a constant need for high-purity media such as puried water, water for injection and high-purity steam. Quality uctuations or supply bottlenecks for these sensitive pharmaceutical raw materials are inacceptable for producers. In other words, high-purity systems are central supply systems which, if they fail or if the quality drops, can lead to far-reaching consequences in the production units. Overview Planning support to help decisions about the most efcient solution (feasibility study on request) Basic and detailed engineering services going as far as qualication (including full-loop calibration) Complete FAT in realistic operating conditions (on request: including endotoxin challenge test) Customized sizes and functions Connections to process control systems (PCS) Individualized software applications User ID password protection to 21 CFR Part 11 Systems integration, e.g. feed water header and WFI tank Support with on-site installation Remote maintenance using modem

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High-purity steam generators from Pharmatec

High-purity steam High-purity steam quantity (kg/hr) for pressurized heating steam 4 bar (g) 6 bar (g) 8 bar (g)

Type PSG 50 E PSG 100 E PSG 200 E PSG 200 PSG 250 PSG 300 PSG 400 PSG 500

pressure (bar)

2 2 2 2 3 2 3 2 3 2 3 2 3 4

50 100 200 45 95 190 375 480 165 690 240 1130 395 1650 505 2105 735 2630 915

50 100 200 80 50 160 110 325 220 650 440 850 600 355 1220 860 510 2000 1405 840 2650 2000 1120 3770 2630 1560 4730 3290 1935

50 100 200 105 80 215 165 410 330 730 660 1120 890 685 1600 1280 980 2900 2085 1600 3800 3250 2210 4940 3930 3000 4950 3790

PSG 600

2 3 4

PSG 650

2 3 4

PSG 700

2 3 4

PSG 800

2 3 4

PSG 1000

2 3 4

Example of a PSG 500 high-purity steam generator

Performance features

Pharmatec is your partner for the development, construction and manufacturing of individual highpurity steam generators. To meet fast deadlines or budget limitations, Pharmatec can provide standard solutions with no reduction in quality.

If a customer has a special request or requirements for the removal of inert gases within the high-purity steam, in accordance with EN285 and HTM2010, with proportions <3.5 by volume, Pharmatec can deliver degassing systems to pre- treat the feedwater. We have membrane or thermal degassing for this application.

Optional: Membrane gas removal A compact vacuum gas removal unit basically consists of a membrane pipe module and a vacuum pump. It works on the basis of gas permeation through a semi-permeable membrane, by applying a vacuum to a ltration module through which the feed water ows. The unit is constructed so that there is no drop in high-purity steam production when the feed water degasier is switched on or operated.

Optional: Thermal gas removal Thermal non-condensable gas removal can be used in special cases and with ozone sanitized systems. It is based on extracting the nely atomized feed water vapor in a degasifying tank. In this process, the feed water is conducted via a heat exchanger, where it is heated to a gas removal temperature, then nebulised using a spray nozzle into a tank which is surrounded by a vacuum.

High-performance units for the generation of high-purity media from Pharmatec

Pharmatec high-purity media generators are constructed following the principle of the natural circulation evaporator. Here, special shell-and-tube heat exchangers are used. The distillation process is based on an energysaving multi-stage principle. Driven by the density gradient, the power of the natural circulation process is used to create a circulating ow without any additional energy. Our engineers and energy experts are constantly improving the energy-efcient methods for the benet of our customers.
Multi-stage pressure column distillation units from Pharmatec These units consist of three to eight columns. The rst is heated with steam (optionally: electricity). The proceeding columns are heated using the high-purity steam produced by the previous columns. The continuous monitoring of the distillate by the control system means that distillate of insufcient quality is rejected. This includes too high conductivity or a non-permissible temperature.

Conceptual diagram of Blow down

Optional: Triple mode still As well as the generation of WFI, there is often a need in pharmaceutical processing units for fairly small quantities of high-purity steam, e.g. to sterilize sampling devices, lab equipment or short pipe sections. The rst column can optionally be used as an independent high-purity steam generator. Small quantities of high-purity steam can also be removed at the same time, i.e. simultaneously, during the distillation process.

Concept sketch of Pharmatec Natural circulation evaporator

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Multi-stage pressure column distillation units from Pharmatec

Distillate production (l/h) with pressurized heating steam

Type 50-S1E* 100-S1E* 50-S1 120-S3 200-S3 250-S4 400-S4 500-S4 700-S4 700-S5 1000-S5 1000-S6 1500-S5 1500-S6 2000-S5 2000-S6 3000-S6 3500-S6 4000-S6 6000-S7

4 bar (g)

6 bar (g)

8 bar (g)

50 100 45 160 250 320 420 660 790 790 1060 1060 1530 1530 1950 1950 3100 3600 3950 4900

50 100 80 220 350 450 680 900 1270 1270 1700 1700 2450 2450 3150 3150 5060 5060 6150 8500

50 100 100 265 410 540 840 1100 1450 1450 2050 2050 3100 3100 4100 4100 6100 6100 8100 12100

Example of a multi-stage pressure column distillation unit, type 1000-S6

Performance features (*electric heating)

Pharmatec multi-stage distillation units are designed for the production of sterile, non-pyrogenic water for injection (WFI). Only the rst column of the distillation unit needs to be heated with plant steam. In the case of units with seven to eight columns with the use of pre-heaters, the WFI product cooler is not required, as an external cooling medium is not needed.

Pharmatec multi-stage distillation units unique process for eliminating pyrogens is based on the complete separation of the feed water and generated steam, with low steam rates. A specially developed bafe/reversing system is designed to almost entirely remove water drops from the steam produced in accordance with pharmaceutical laws.

feed water

pure steam

ON for WFI generation

cooling water heating steam

ON for RD generation

WFI

condensate

ON for combined WFI/RD generation

waste

Concept sketch of Triple mode still

Customized quality units from Pharmatec

Successful projects start with project management Efcient, transparent project management: we constantly inform you about the projects progress Pharmatec is certied in accordance with DIN EN ISO 9001:2000 Shorter delivery times for fast-track projects available on request Successful projects need qualied staff Process engineers and software engineers with many years processing expertise in planning, construction and automation Practice-oriented mechanics, orbit welders and exible tters in production and nal assembly Experienced service technicians can take on various tasks on our customers sites Specialists and experienced qualied staff fulll our customers individual requirements and wishes Successful projects can be proven Manufacturing traceability Documentation in all main languages from the rst R&I draft until handover cGAMP documentation Successful projects end with a high-quality product which meets your demands Compact construction with minimum oor space required Parts which come into contact with products come completely in premium steel 1.4404/1.4435 (AISi 316L) Frame prole, insulating sheath and switch cabinet in premium steel (AISi 304) Control components from Siemens, Allen-Bradley, Schneider Telemecanique Manufactured in accordance with the European Pressure Equipment Directive 97/23/EC, ASME, SVTI, CODAP Exceeds all requirements in the United States Pharmacopeia (USP), European Pharmacopeia Effective separation of pyrogens at low steam speeds Suited for low or changing pressure of heating steam or feed water Improved setup for high efciency On request: Ra < 0,5m surface qualities and electropolishing Delta-ferrite content of 0.5% to 1% Specially manufactured fittings and meters

Pharmatec develops, constructs and manufactures: WFI storage and distribution systems PW storage and distribution systems Distribution systems for high-purity steam

P+I-Diagram

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Storage and distribution systems for WFI, PW and high-purity steam from Pharmatec

In pharmaceutical production, high-purity media systems are used to supply the most important processes. Highpurity media such as WFI and PW are generated, stored, distributed and used. So that enough medium of sufcient quality is available for every recipient at all times, the storage and distribution system is customized to precisely suit the requirements of the production or lab area. Requirements for the material, the selection of the components themselves and the fulllment of legal regulations for pharmaceutical construction play a decisive role in fullling the high quality requirements for WFI and PW storage systems.

GMP- and FDA-compliant setup and adaptation of production efciency to t with storage capacity and quantities purchased Validation and guaranteeing of parameters critical to the process (ow rate, throughput, pressure, temperature, conductivity) FAT at Pharmatec on test benches with equipment to provide realistic proof that the unit fulls all user requirement specications (URS) Route planning Tap connection management Assembly management

Pharmatec GmbH A Bosch Packaging Technology Company Elisabeth-Boer-Strae 3 01099 Dresden Germany Tel. +49 351 28278-0 Fax +49 351 28278-662 www.pharmatec.de

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