bram-cor - pharmaceutical water treatment systems

7/27/2019 Bram-cor - Pharmaceutical Water Treatment Systems

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PURIFIED

WATER

WATER FORINJECTION

PURE STEAM

WATER

TREATMENT

SYSTEMS


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BRAM-COR Pharmaceucal Water Treatment Systemsare designed to produce

compendial:

- PW PURIFIED WATER

- HPW HIGHLY PURIFIED WATER

- WFI WATER FOR INJECTION

- PS PURE STEAM

Pre-treatment opons, monitoring of crical parameters, regulatory requirement

for product quality, consumpons, microbiological control, operaon and mainte-

nance requirements, lifecycle costs are taken into consideraons in the design of

all processing steps, from feed water to the point of use.

Special care is given to the choice of sanitary materials. Product-contact surfaces

are in cered AISI 316L stainless steel, with standard roughness 0.4 m.PTFEgaskets ensure perfect sealing. Advanced Process Analycal Technologies

are applied for monitoring issues and professional GAMPcompliant automaon is

provided for system control.

BRAM-CORWATER TREATMENT

LINES

Boilers and pressure vessels in BRAM-COR water treatment and pro-

cessing systems are ASME cered (S and U stamp).


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PRTW Water Pre-treatment Systems 4

CROS Reverse Osmosis Systems 5

STMC Vapor Compression Distillers 6

SMPT Multiple Effect Distillers 7

CPSG Pure Steam Generators 8

DPSG Single Effect Distillers 9

LOOP Distribution Systems 10

SCADA Control Systems 11

DTS Heat/Cool Exchangers 12

STOC Storage Tanks 13

KOMB WFI + PS Generators 14

GENO Ozone Generators 15

UVITRON UV-C Reactors - Controls and Lamps 15

STDA Standard Accessories & Components 15


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BRAM-CORWater Pre-Treatment Systemsare cus-

tomized upon a thoroughful evaluaon of feed-

water quality using the customers water analysis.Raw water can be pre-treated to remove contami-

nants (such as parculates, calcium and magne-

sium salts, heavy metals, organics and bacteria)

through dierent steps, including:

- UV lamps

- Ozone units

- Cartridge microfiltration

- Ultrafiltration units

- Multimedia filters

- Automatic duplex softeners

- Industrial RO

Chemical dosing staons are added for water disinfec-

on and/or chlorine neutralizaon. Pretreated water

quality is constantly monitored to ensure suitability

to feed downstream water treatment equipments,

such as RO units or disllers. Standard versions are

designed for CIP sanizaon.

Upon request, for an eecve microbial control strategy to prevent biolm formaon, most pre-treat -

ment systems can be supplied in hot water sanizable version.

CAPACITIES RANGE

From 100 to 20,000 lph

PRTW WATER PRE-TREATMENT SYSTEMS


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CROS REVERSE OSMOSIS SYSTEMS

CROS Reverse Osmosis Systems are designed to produce compendial puried and highly puri-

ed water through several water treatment steps, according to feed water quality and producon

needs. Water treatment steps, which are necessary to separate the water from organic substances,high and medium molecular weight ions, and from some bacteria and pyrogenes, may include:

- Sodium hypochloride dosing staon

for water disinfecon and oxidaon

of organic substances,

reducing the bacterial charge

- Sodium metabisulphite dosing

staon for neutralizaon of calcium

carbonate and chlorine

- 25 m + 5 m ltraon system

to eliminate solid substances

in inlet water

- Single or double osmoc stages

- Electrodeionizator

- UV lamp

CAPACITIES RANGE

From 100 to 20,000 lph

purified watergeneration

Puried water is usually obtained throughsingle stage RO + Electrodeionizaon,double stage RO

and double stage RO + EDI.In each RO stage, water is processed through thin lm composite RO

membranes, oering the highest rejecon of contaminants. Two dierent ows are generated by

the RO system: permeate water, corresponding to PW specicaon, and RO concentrate, which isrecycled in the system in order to obtain a higher recovery with a lower consumpon of inlet water.

CROSequipments, with a range of capacity spanning from 100 up to 20,000 lph, are manufactured

according to all cGMP and FDA rules, including:

- Centrifugal booster pump in

AISI 316L stainless steel,

completely mirror polished both

internally and externally

- AISI 316L stainless steel membrane vessels

- Sanitary in-line instrumentaon

to monitor product crical parameters,

such as conducvity and temperature

- Full automaon managed throughGAMP-compliant hardware and soware

- Framework and control board in AISI 304

stainless steel san nished

- CIP sanizaon or HOT WATER

sanizaon.


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STMC VAPOR COMPRESSION DISTILLERS

BRAM-CORSTMC Vapor Compression Disllersproduce compendial dislled water for pharmaceu-

cal applicaons, such as I.V. soluons, injectables, washing systems and special soluons where

both quality factors, such as the sterility, eliminaon of the pyrogens and of the chlorine solventswith low molecular weight,

and economical factors, as

well as the low producon

costs, are crical for the suc-

cess of the pharmaceucal

process.

STMCvapor compression dis-

llers can operate:

- With electrical heang

- With steam heang

- Both with electrical

and steam heang systems

CAPACITIES RANGE

From 20 to 12,000 lph, with

single or double compressor

wfi at extra low management costThe STMC disller can produce both cold disllate at a tempera-

ture and hot disllate with huge savings of energy costs and with no

need of cooling water. The design, construcon and documentaon

of STMC disller strictly complies

with cGMP and FDA regulaons,

ensuring an easy cercaon bythe relevant authories. In detail:

- The disller is made in cered

AISI 316L stainless steel

- All internal parts in contact with

infeed water, Pure Steam and

Disllate, are mirror-polished

- AISI 304 frame, jackets and control board

- All hydraulic connecons are sanitary tri-clamp

or ange connecon

- All gaskets are made in PTFE

- All weldings are T.I.G. (Tungsten Inert Gas)

Vapor is compressed by the special blower. A full automaon en-

sures easy operaon and total monitoring of crical parameters,

by means of cered in-line instruments and of a careful alarm

policy. Access policy and records can be managed according to

21 CFR PART 11.


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SMPT MULTIPLE EFFECT DISTILLERS

BRAM-COR Mulple Eect Disllersare designed and manufactured according to cGMP to pro-

duce compendial Water for Injecon. Each unit contains a number of boiling columns (or eects),

with the rst column producing Pure Steam, which is either condensed in the following columnsdecreasing the operaonal costs, or used as PS. Heathing for evaporaon and cooling for conden-

saon processes are performed by double tube sheet heath and cool exchangers. Condensaon

is achieved by means of

the thin-falling lm sys-

tem. The process is re-

peated in each column;

the higher the number,

the lower the consump-

on of the equipment.

CAPACITIES

RANGE

From 50 to 15,000 lph,

with three-ten columns

conguraons

A special labyrinth-separator installed at the top of each column

separates the steam generated by the evaporaon process from

entrained substance in the steam itself. The result is a pure, dry,

pyrogen-free steam, condensed in compendial Water for Injecon.

Pressure vessels are designed according to PED regulaon, and the

equipment features:

- Double tube sheet heath exchangers

- Cered AISI 316L stainless steel mirror-polished

and passivated product contact surfaces

- AISI 304 frame, jackets and control board

- PTFE gaskets

- Pneumac valves with PTFE membranes

and AISI 316 L SS electro-polished body

- ASTM C-795-compliant insulaon

wfiwith minimal moving parts


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BRAM-COR CPSGPure Steam Generators produce dry, saturated steam, suit-

able for sterilizaon of pharmaceucal producon plants, for direct contact

with acve pharmaceucal ingredients, for parenteral and non-parenteral

dosage form applicaons. The steam, when condensed, meets USP require-ments for Water for Injecon. The steam is puried using centrifugal and grav-

ity separaon methods.

CAPACITIES RANGE

From 20 to 5,000 Kg/h

CPSG PURE STEAM GENERATORS

cGMPand PEDstandards are baseline criteria in BRAM-COR CPSG Pure Steam

Generators design and construcon: material and instruments are cercated

and all welds are made by qualied welders.

In detail:

- The evaporaon column is designed to minimize steam speed to avoidthe entrainment of water droplets, which are separated from the steam by

means of a special separator.

- A Double Tube Sheet Heath Exchanger provides heat-

ing of pre-treated feed water above the boiling tem-

perature, generang Pure Steam which expands into

the evaporaon column. Heathing medium in the DTS

Heath Exchanger is typically industrial steam at 100 to

120 psig (7.9 to 2.0 bars).

- Pure Steam pressure is maintained by an electronic

control system, modulang the supply steam control

valve and monitoring the evaporator feed water.

The system shall be fed with Puried Water.

BRAM-COR KPSG Kele Pure Steam Generators pro-

vided with a horizontal evaporaon chamber with ket-

tle end, are also available for special space needs.


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PS &WFI from a single eect disller:

each BRAM-COR DPSGequipment is

both a Single Eect Disller and a

Pure Steam Generator. This equip-ment produces dry, saturated steam

to be used as sterilizing agent.

The Pure Steam, when condensed

through a double tube sheet con-

denser, meets the requirements of

internaonal pharmacopoeias for

Water for Injecon. The system can

therefore provide a simultaneous

producon of Pure Steam and Water

for Injecon. The producon process

consists in PW water evaporaon fol-

lowed by Pure Steam separaon and

condensaon.

The steam is puried using centrifugal and gravity separaon methods. The equip-

ment is made in AISI 316L stainless steel for all parts in contact with the process

uid and steam, and it is designed according to European PED pressure regulaon.

All pipes are orbital welded when

possible, with inert gas protecon.

Moreover:

- Acve surfaces are passivated.

- The parts in contact with the pure

steam are polished (Ra 0.4 m)

- The Skid is in stainless

steel AISI 304 san nished- The Control Cabinet is in stainless

steel AISI 304 san nished

BRAM-COR DPSG equipments are

available in electrically or steam heat-

ed versions.

DPSG SINGLE EFFECT DISTILLERS


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LOOP DISTRIBUTION SYSTEMS

BRAM-COR integrates its PW - WFI - PS Generaon Equipmentwith state-of-the-art distribuonloops. Loop design is the result of a careful evaluaon of Points of Use delivery criteria such as:

- Maximum istantaneous ow rate

- Pressure & temperature

requirements

- Sanizaon issues

- Periodic consumpon

requirements and duraon

- Method of delivery

(automac or manual)

Loop construcon is carried out by quali-

ed welders following BRAM-COR sani-

tary piping procedures, according to ASME

standards. All pipelines are passivated and

inspected, according to ASME/BPE accep-

tance criteria, to check quality of welds, ef-

fecve passivaon, hydrostac ghtness,

full drainability, absence of dead-legs, uid

dynamics.

A thoroughful loop documentaon, includ-

ing isometric drawings, welding reports,

boroscopy records, passivaon cercate

and test reports is provided to complete thesupply.


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BRAM-COR GAMP-Compliant Automaon: from equipment control to producon line supervi-sion, SCADASystemsprovide full management control throughout the plant lifecycle. Data man-

agement includes: trends and electronic records, electronic signatures and alarms management,

audit trails, lifecycle check counts, display of manuals & documentaon.

The soware is usually congured on WinCC Flexible plaorm. Other plaorms may be used upon

request, as Rockwell Allen/Bradley. Secure access policy, according to 21 CFR PART 11, includes

three dierent access levels. Each authorized user shall log-in by diging user ID + password, the

combinaon of which is unique and may be changed by the Customer in runme. BRAM-COR

control systems are congured to store and show live-data for one year. Dierent needs shall behighlighted by the Customer and involve HD of bigger size for a dierent conguraon of WinCC

Flexible program.

All historical data can be exported and saved by the Cus-

tomer for long lasng backup. All parameters modied by

the customer are stored and limited, all parameters and I/O

(analogic and digital) of the system can be printed on the re-port, allowing a quicker assistance, in accordance to 21 CFR

PART 11. Start/stop of operang modes are recorded on the

audit trail. Audit trail le can be exported by the Customer on

a USB key or Ethernet.

SCADA CONTROL SYSTEMS

gamp-compliant automation


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A heat/cool exchanger is due to heat up, cool down or keep process water temperature to the

desired values, by heat transfer between two uid media. For eciency, BRAM-COR Double Tube

Sheet Heat/Cool Exchangersare designed to maximize the surface area of the wall between the

two uids, while minimizing resistance to uid ow through the exchanger.

Tube diameters, thickness, length and number are calculated to withstand internal tube pressure

and shell overpressure in accordance to space and performance requirements.

In pharmaceucal processes, BRAM-COR DTS

exchangers are typically used for high pres-

sure applicaon, for hot water sterilizaon of

loops and tanks, for water cooling/heang user

points. All product contact surfaces are built in

AISI 316 L stainless steel, internally mirror pol-

ished, Ra 0,4 m.

The exchangers are insulated and clad with 304

SS san nished. Tube ends are manually ex-

panded to t in the tube sheet. All materials are

fully traceable. Non-destrucve tests are carried

out by skilled personnel to ensure compliance

to cGMP and Pressure Equipment Direcve.

DTS exchangers may be embedded in the equip-

ment (ex. in SMPTdisller) or on self-standingskid, and ed with sanitary valves and pumps,

steam trap, temperature probe.

DTS HEAT/COOL EXCHANGERS


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BRAM-COR STOCStorageline includes a complete range of pharmaceucal hold-

ing tanksfor storing compendial or non-compendial water.

STOC STORAGE TANKS

high quality pharmaceutical vesselsMaterial and components traceability and cercaon are assured in all BRAM-COR vessels. Rigor-

ous sanitary piping welding and inspecon procedures, ND tesng procedures in compliance to in-

ternaonal standards for pharmaceucal equipment are enforced in our workshop. Basic features

of our fully cleanablestorage tanks:

- Cered AISI 316L stainless steel mirror-polished (Ra 0,4 m)

product contact surfaces and components

- Tank in tank insulaon boom and wall

- Vercal or Horizontal design

- Customized heath and cool jackets, cladded in san nish

AISI 304 stainless steel

- Manhole

The capacies range from 100 up to 25,000 litres, while sizes and shapes are

scaled up according to specic URS, in order to t dierent space require -

ments including for instance:

- Any instrumentaon / control / management system- Heang and cooling systems

- Plaorms and stairs

- PED cercaon upon request

All tanks can be integrated with

BRAM-COR SCADA computer-

ized control system, managing

PW or WFI generators, loop

and user points, which also

records and produces the les

and documents necessary for

the internaonal pharmaceu-

cal validaon.


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BRAM-COR KOMBis a unique equipment for the simultaneous producon of WFI and PS, combin-ing the double funcons of a mulple eect disller and of a Pure Steam generator on a single skid,

shrinking space needs.

A central SCADAcontrols the two units, providing separate or concurrent outlet of Water For Injec-

on or/and Pure Steam.

KOMB COMBINED WFI + PS GENERATORS


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Special sanitary components in AISI 316L aremanufactured by BRAM-COR to t our water

treatment systems, such as:

- 316L SS housings for water lters

- 316L SS housings for air lters

STDA STANDARD

ACCESSORIES

AND COMPONENTS

Thanks to its high oxidaon potenal, ozone is

proven to be one of the most eecve and safe

methods to remove anbacterial, an-viral, and

an-fungal acvity.

sterilizing pw loops

pw storage tanks

BRAM-COR full-stainless steel GENO Ozone

Generators are conceived for pharmaceucal

applicaon, i.e. for water disinfecon and loop

sanizaon.

Ozone quanty during and aer sanizaon

is constantly monitored by ozone analyzers,

while residual ozone in water is automacally

destroyed by a sanitary UV lamp before the use

in the process.

Sanitary piping, valves, pumps and instruments

complete each GENOunit.

GENO OZONE

GENERATORS

UVITRON UV-C REACTORS

UV Reactors for pharmaceucal purposes, witha full range of capacies, from one to eight

lamps unit, are manufactured and customized

following rigorous cGMP-compliant Standard

Operave Procedures.


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BRAM-CORSPA-022018DATAMAYCHANGEWITHOUTNOTICE

BRAM-COR S.P.A - V. MERCALLI 12/A - 43122 PARMA - ITALY - TEL +39 0521 538711 - FAX +39 0521 538770

[email protected] - www.bram-cor.com - P.IVA 01699350342

WORLDWIDE SERVICES

We are currently delivering our machines and building complete water treatment systems and preparaon lines all over

the world. Top quality GMP equipment must necessarily be integrated through a proper high level of professional services

including: Technical Documentaon, Factory Acceptance Test, Installaon, Commissioning, Site Acceptance Test & Start-

up, Training, Validaon,Afer Sales Service. Our worldwide network of skilled agents and our aliated companies ensure

assistance to our Clients in over 50 countries, from the very beginning of a pharmaceucal project throughout decades

aer start-up. OurAfer Sales Dept. grants punctual and quick deliveries of spares and ongoing technical support.

A full understanding of the drug producon process is the key con-

cept for correct design. BRAM-COR engineering focuses on uid

drugs sterile producon processes, such as parenteral soluons,

oral soluons, ophtalmic soluons. The denion, assessment and

monitoring of crical parameters directly aecng product qual-

ity are the baseline for the applicaon of suitable Process Analy -cal Technologies for in-line and at-line quality control. BRAM-COR

work breakdown structure consists in following main acvies:

- Design

- Construcon (mechanical, electro-

pneumac, SW conguraon)

- Tesng

- Documentaon

- Installaon

- Validaon

- Assistance

Every process follows rigorous cGMP-compliant Standard Opera-

ve Procedures. Specicaon, construcon and vericaon steps

within the lifecycle are carried out according to GAMP V-model,

considering risk assessment, architecture of system components,

funconal specicaon, sanizaon and validaon issues with spe-

cial overview to a sustainable maintenance of the system.

BRAM-CORKEY DESIGN CONCEPTS

bram-cor - pharmaceutical water treatment systems

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