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