CAMSAFE 3

CAMFIL IS THE WORLD LEADER IN AIR

FILTERS AND CLEAN AIRSOLUTIONS.
Camfil is the global industry leader in clean air solutions with 50+ years of experi-
ence. Our solutions protect people, processes and the environment to benefit human
health, increase performance, and reduce and manage energy consumption. Twen-
ty-five manufacturing plants, six R&D sites and over 65 local sales offices worldwide
provide service and support to our customers. The Camfil Group is headquartered
in Sweden but more than 95% of sales are international. The Group has about 3,800
employees and sales more than SEK 6.0 billion (2015).

© 2 016 0 4

WWW.CAMFIL.COM
For further information please contact your nearest Camfil office. Clean Air Solution
Camsafe 3

CAMFIL-VENTILATION FILTER FOR A NEW GENERATION OF VENTILATION FILTER

SAFETY PROTECTION
Strengths
Camfil is the global leader in clean air technology
and air filtration equipment manufacturing area.
Camfil was founded in 1963, headquartered in
Stockholm, Sweden. Today it has 25 factories
and 6 R & D centers all over the world, with sub-
sidiary companies, representative offices and
distributors in more than 50 countries and re-
gions. Camfil China has an office in Shanghai and
a factory in Kunshan with more than two hundred
Segment focus
Think what you want, do what you need
Many industries are devoted to our dedicated
services, Camfil has already gone beyond a sim-
ple filter brand, but is a symbol of air filtration
expertise in these industries, focusing on the
technology development of industries, foresee-
ing the potential customer needs, sharing inter-
national experience, and heavily investing in R &
IN SAFETY PROTECTION SYSTEM- CAMSAFE 3
In order to standardize and guide the design, construction, operation and management of biological safety laboratories, international authority organi-
zations have formulated a number of standards, norms and guidelines. Chinese standards such as GB 19489-2008 ” laboratories - General biosafety
requirements “ and GB50346-2011 ” biological safety laboratory construction technical specifications have been developed by considering the inter-
national standards and the construction and operation experience of the domestic and international bio safety labs.
In view of the high class biosafety laboratory, the new standards add and emphasize the mandatory requirements for ventilation and filtering techno-
logy of safety protection systems, in-situ decontamination, in-situ leak detection, air tightness test and bring the security to a new level in line with
international standards.
BMBL 5th Edition WHO-2004 HC 2004/CFIA-1996 ARS 242-2002 China GB19489-2008

BSL-3ag

BSL-3ag

BSL-3ag
animals
ABSL-4

ABSL-4

ABSL-4
ABSL-3

ABSL-3

ABSL-3
BSL-4

BSL-4

BSL-4

BSL-4
BSL-3

BSL-3

BSL-3

BSL-3
D and solution design. Reliable and professional

AP-4
AP-3
CL-4
CL-3
employees.

Our mission is to protect people, products and
the environment from pollutants, we insist to
provide sustainable and high-quality air filtration
solution to customers, and constantly exceed
customer expectations.
Experience
Camfil’s industrial experts all over the world
and long-term investment in R & D enables us
to fully understand the real demands of custom-
ers; we understand a single small leakage in
safety protection system could cause a major
accident, which can cause a delay or shut down
in the manufacturing or research activities, and
great damage to personnel and the surrounding
environment; we understand the importance of
maintaining normal operations for facilities when
carrying out test and validation programs; and
understand that security will never be under esti-
mated.
Therefore, to ensure the reliability of ventilation
systems in safety protection, not only the re-
quirements of manufacturing and test should be
in accordance with the most stringent interna-
tional standards and quality assurance systems,
but also the ability to perform on-site tests is
required. It sounds simple, but in actual is never
easy.
1 2
big
solutions are ready before the customer comes
one stage air supply safety
to Camfil. protection system
one stage air supply safety protection
For over fifty years, Camfil has been a leading system(in-situ sterilization function
and leak test function)
partner in air filtration for safety protection in life
one stage air exhaust safety protection
science industry. The continuous development system(in-situ sterilization function and
leak test function)
of pharmaceutical facilities, process equipment two stages air exhaust safety protec-
and biosafety research institution drive Camfil tion system(in-situ sterilization function
and leak test function)
research and develop products to meet the
Must Rcommended or Risk Assessment
needs of a variety of complex applications. For
decades, the technical experts in Camfil have Within international scope, more and more facilities used for vaccine, biological agents, highly sensitizing drug production are using exhaust air design
accumulated air filtration experience in safety standards of bio safety lab laboratory. In the safety protection of life science industry, Merck (Merck), the Ya Pei Laboratory (Abbott), Syntex, Eli Lilly (Eli
protection, which can also be applied to other Lilly) and PU (Upjohn) and other companies formed a pharmaceutical industry security team in the late eighties of the twentieth century, and came up with
industries. classification method of some compounds. Grading method of hierarchical control system refers to the biological safety standards of BSL 1-BSL 4, and it is
called „Merck model“ and published in Journal AIHA in 1996.
Main applications
Camsafe 3 is a new generation of air supply and exhaust filter safety protection system in full compliance with the ventilation and safety protection require-
Pharmaceutical ments from national standard GB19489-2008 „laboratory bio safety general requirements“ and GB50346-2011 „biological safety laboratory of construction
• Vaccine production, exhaust air technical specifications“. Also comply with China GMP EU/GMP and FDA-cGMP standards, which address requirements of pharmaceutical production env-
• Animal vaccine, supply/exhaust air ironment ventilation safety protection.
• Beta lactam drug production, exhaust air Professional and attentive - precisely positioning your safety needs!
• Hormonal, cytotoxic drug production, exhaust air
• High active chemicals production, exhaust air
1 2 3 3+ 4 5
• Anticancer agent production, exhaust air
Exposure
暴 露 控 control
制 限 值limit
• Isolator equipment, supply/exhaust air
>1mg/m 3
> 1mg/m 3
100µg/m3 10µg/m3 1µg/m3 <1µg/m3
Biological safety laboratory ventilation
>10mg/100cm2 10mg/100cm2 1mg/100cm2 100µg/100cm2 10µg/100cm2 <10µg/100cm2
Hospital with negative pressure and isolated Control range, HSE risk level and Merck PB-ECL level grades contrast
zone, exhaust air control concentration request HSE risk level Merck PB-ECLgrades
>1-10mg/m3 A-Industry hydienic standard 1.Good Manufacture Practice of Drugs
• The negative pressure operating room and
>0.1-1mg/m3 B-Local exhaust 2.Good Manufacture Practice of Drugs(Local exhaust)
negative pressure wards
>0.01-0.1mg/m3 C-closed circuit 3.No open manufacturing processes recommended(closed vetilation
• Experimental animal room >0.001-0.01mg/m3 D-Consult expert opinion 3+.No open manufacturing processes
Industrial hazardous gas exhaust (chemical) ≤0.001mg/m3 D-Consult expert opinion 4.Isolation process(physical isolation system)
≤0.001mg/m3 D-Consult expert opinion 5.No control or cotacat for people(full automation or remote control)
Camsafe 3
CAMSAFE 3-OUTSTANDING QUALITY BEYOND INDUSTRY
Function
• To contain a variety of supply and exhaust air pollutants,
an efficiency of 99.995% could be achieved.
• Ultrafine particles including: bacteria, virus, cell
fragments, aerosol and powders.
• Gas molecules including: toxic gases, odors, ammonia,
ozone, formaldehyde,VHP,ClO2 and toluene
• Maximum air volume:
3400 m3/h (single channel module)
6800 ~ 20400m3/h (muti-channel module)
For more information please see the filter parameters
• BIBO filter change, easy for maintenance.
• In-situ filter scanning test after installation.
• Aerosol injection and uniform mixing.
• Optional pressure gauge, real time pressure monitoring
and remote signal output available
• Optional zero leakage dampers for single channel or
muti-channel module
• System air tightness FAT and SAT test is also available.
• Optional decontamination ports with zero leakage isolati
on valves available.
• Construction in stainless steel or epoxy powder coated
carbon steel depending upon the environment requirement.
A series connection of different filter housings to satis-
fy every application.
Inlet plenum
Pre-filter
Upstream
test section
HEPA filter
Downstream
test section
Molecular filter
Outlet plenum
3 4
Air tightness NIFV Non-intrusive integrity validation
All individual components are fully welded and are able to withstand +/-5000Pa in- The equipment can be quickly connected to an
ternal pressure, the airtightness meets all relevant international standards: aerosol generator, photometer or laser particle
counter. All the HEPA filter scanning validation
EUROVENT 2/2:Class C test can be carried out without any requirement
to open the filter housing or disturb the pressure
EN1886: Class L1 boundary. The sample probe is within 30mm of
the filter downstream clean surface and there
ISO 10648-2: Class 3
are no obstructions that may compromise the
result.
EN 12237:Class D
ClampSafe safe clamping system Upstream test section
The filter clamping mechanism of ClampSafe cannot The test particle injection system provides uni-
be operated before the filter is installed correctly. form mixing of the upstream aerosol.
The filter gasket is a half round conti- To ensure the test result is reliable, the con-
As a safety feature the main cover cannot be re-
nuous expanded polyurethane foam. centration and uniformity of the aerosol is in
placed until the ClampSafe mechanism has correct-
The leakage shall be less than 0.01% accordance with the requirement of international
ley clamped the filter against the seal face.
between the filter and the housing and standards.
will meet the requirement of internatio- The patented ClampSafe design ensures the
nal standard ISO 14644-3. Camsafe 3 filter safety protection system will not
allow any operation unless the filter is installed cor-
rectly, this provides a low risk of a leakage accident
due to incorrect filter installation.
BIBO Filter Change
BIBO filter change makes the filter change a con-
tact free and safe process, known as Bag In Bag
Out(BIBO) or Safe Change. The safe change bag is
made from a PVC material, heat resistance, ageing
Inlet plenum resistance and air tightness have all been tested
and validated. For convenience during the filter
Upstream change process there are gloves built into one side
test section of the safe change bag structure.
HEPA filter and “Scannable” HEPA Filter
test section
The Camfil Absolute D series is high air flow HEPA filter with a single flat non separator media pack, it can therefore be scanned and tested by a straight line
sampling probe to ensure its Integrity and strictly comply with the EN 1822 standard. All Camfil HEPA filters are factory scanned and tested for efficiency
Outlet plenum
and the air uniformity checked.
Each HEPA filter is given a unique serial number and a traceable test report.
Camsafe 3

SYSTEM MODULE AND MODEL

2

REPRESENTATION
3
1 product model : CamSafe 3 (CS3) 6 inlet and outlet plenum

• In multi channel parallel arrangement, multiple unit ventilation sys-

2 Main module size tems are connected together through inlet/outlet plenum section.
1
6
• Air inlet plenum is in upstream of the HEPA section, outlet plenum is
Filter size(mm x mm) in downstream of the HEPA section.

• An air inlet connection flange is usually an optional for the air inlet
305 305X610
305 610 plenum. The position could be 1,2 or 3 in the picture.
610 610X610 4
• An air outlet connection flange is usually a optional for the air outlet
*610 Is always the width size that facing the door for replacement.
plenum. The position could be 4,5 or 6 in the picture.

3 Multistage filter module: CamSafe 3 (CS3) 5

Naming rules – Camsafe® 3 Ventilation filtering for safety protection system

Coarse filter qty. HEPA qty.
1 2 3 4 5 6 7
(width: 45mm) (width: 292mm)
CS3 — 610 — PF+TSU+F+F — SS — 6 — 1/6 — scan10
F 0 1
PF+F 1 1 F PF + F F+F PF + F + F
1 Product name 5 System channel module number 7 Test section

F+F 0 2 CS3 – CamSafe 3 1 – Single channel module 00 – none for test section
PF+F+F 1 2 2 – Two-channel module scan – HEPA test section
2 2standard sizes for housing (AxB) 3 – Three-channel module
st
scan10 – 1 stage HEPA test section
nd
4 – Four-channel module 2 stage without HEPA test section
• The main filter is usually HEPA,could be replaced by HEPA and molecular filters stages or two HEPA stages; When the molecular filter and HEPA in sta- 610 – 730x725 mm st
5 – Five-channel module scan01 – 1 stage without HEPA test section
ges, molecular filters are usually after HEPA (Size/with filter : 610x610mm) nd
6 – Six-channel module 2 stage HEPA test section
305 – 730x420 mm
• When the customer need to do the SAT test for the HEPA. A test section should be added between Pre-filter and HEPA filter, it is expressed as TSU in scan11 – both test section for
(Size/with filter : 305x610mm)
6 air inlet/outlet
st
1 stage HEPA and
model name.
nd
2 stage HEPA
1 – above left inlet
3 Filter arrangement
2 – above middle inlet
4 Housing Material PF – Pre filter section 3 – above right inlet
F – HEPA section 4 – below left outlet
• The housing is made of painted galvanized steel, filter clamp is made by 304 stainless steel
F+F – two series main filter 5 – below middle outlet

• The housing is made of 304 stainless steel, filter clamp is made by 304 stainless steel TSU – HEPA upstream test section 6 – below right outlet
NC – none for both
The model is arranged by the air flow direction

4 Housing material
5 Multi channel parallel arrangement

• To meet the requirements of larger volume by arranging multiple channels in parallel SS – 304 Stainless Steel
PPC – Strucature material is painted carbon steel
• 2~6 module in a parallel arrangement is avaliabe, air volume is 2~6 times of the
single channel system Sample : CS3-610-PF+F-**- 2 -1/6 -scan

5 6
Camsafe 3

MODULE SIZE
Basic Module Single Channel Module Dual Channel Parallel Module Three Channel Parallel Module Four Channel Parallel Module Five Channel Parallel Module Six Channel Parallel Module
CS3-*-** CS3-*-**-1-1/6-** CS3-*-**-2-1/6-** CS3-*-**-3-1/6-** CS3-*-**-4-1/6-** CS3-*-**-5-1/6-** CS3-*-**-6-1/6-**
*305: 1600m3/h *305: 1600m3/h *305: 3200m3/h *305: 4800m3/h *305: 6400m3/h *305: 8000m3/h *305: 9600m3/h
610: 3400m3/h 610: 3400m3/h 610: 6800m3/h 610: 10200m3/h 610: 13600m3/h 610: 17000m3/h 610: 20400m3/h
730
710
585
460
535
425

445
37.5
289

214
827
535
535
1076
535
289
535
1371
535

Flange Size – 305 series Single Channel Dual Channel Three Channel Four Channel Five Channel Six Channel Flange Size – 610 series Single Channe Dual Channel Three Channel Four Channel Five Channel Six Channel
System System System System System System System System System System System System
1600m3/h 3200m3/h 4800m3/h 6400m3/h 8000m3/h 9600m3/h 3400m3/h 6800m3/h 10200m3/h 13600m3/h 17000m3/h 20400m3/h
730 730
3X180=540
3X180=540

3X180=540
368
420

180
471
493

725
673

798
776

Up: flange size without plenum chamber

52

Right: plenum chamber connection size

Up: flange size without plenum chamber
7 8
Right: plenum chamber connection size
Camsafe 3

CAMSAFE 3 IN-SITU SCANNING TEST SYSTEM TECHNICAL PARAMETERS OF FILTER

LEADING TECHNOLOGY, LARGE BENEFIT!
Non-intrusive filter integrity testing system Coarse filter
Upstream test section:
Width Height Depth Air flow/Pressure Drop Efficiency Volume Weight
aerosol injection Model NO.
• The non-intrusive filter integrity testing is a test method mm mm mm m3/h/Pa EN779 m3 kg
and uniforming
without opening any doors or removing any parts in the
equipment, it does not damage the system pressure bounda- 30/30 CL2 305X610X45 305 610 45 1700/70 G4 0.01 0.40
ry condition.This in-situ filter integrity test method is simple, 30/30 CL2 610X610X45 610 610 45 3400/70 G4 0.02 0.80
convenient and safe
Upstream aerosol
• All the connections are standard quick connect/discon- sampling

nect, they will not lead to any leakage during the connection
process, after removing all interfaces the connection will
Fine filter
automatically close and be air tight to ensure no leakage. The Media area
Width Height Depth Air flow/Pressure Drop Efficiency Volume Weight
whole equipment can perform air tightness test on site Model NO. m2
mm mm mm m3/h/Pa EN779 m3 kg
Downstream scan

• In full compliance with the SAT requirements for testing mechanism and
sampling 3GGM-122412-90 305 610 292 6.1 1700/105 F7 0.05 5.4

To ensure efficiency and more reliable 3GGM-242412-90 610 610 292 12.3 3400/100 F7 0.11 9.6

3GGM-122412-95 305 610 292 6.1 1700/135 F8 0.05 5.4

• We are aware of the importance of individual filter scan
testing for system safety 100% 0% 3GGM-242412-95 610 610 292 12.3 3400/130 F8 0.11 9.6
Probability of mis-finding the leakage

Probability of finding the leakage

5 10 20
2
• Factory scan tests are performed before delivery, individ- 80% 1 20%

ual scanning test report provided (EN1822) 60% 40%

40% 60%
• At the same time, we ensure that we can perform same
HEPA
accurate and reliable tests of installed filters on site Media area
20% 80%
Width Height Depth Air flow/Pressure Drop Efficiency Volume Weight
Model NO. m2
100%
mm mm mm m3/h/Pa EN779 m3 kg
0%
0 0.5 1 1.5 2

Reliable aerosol injection, mixing and sampling device Only when the upstream dust particle concentration is high enough, that is, to identify the leakage
DR13-305X610X292-P0-WW-V 305 610 292 16.9 1600/250 H13 0.05 12.3
probability curve provisions tends to be more vertical, scan test laser particle counting method
• Upstream particle concentration sample port was more accurately detect the leakage of HEPA/ULPA filters. DR13-610X610X292-P0-WW-V 610 610 292 39.3 3400/250 H13 0.11 18.7

HEPA Upstream aerosol uniformity verification DR14-305X610X292-P0-WW-V 305 610 292 16.9 1350/290 H14 0.05 12.3
• The HEPA filter upstream aerosol mixing uniformity (IEST-
RP-CC034.3\ISO14644-3\GB50591\FDA Guidance for Industry) DR14-610X610X292-P0-WW-V 610 610 292 39.3 3200/290 H14 0.11 18.7

• Validation of downstream scan sampling device

More convenient, less problem, less cost

Molecular filter(HEGA)
• In situ aerosol injection and sampling, no need to operate Mechamical
Residence
from control area The sampling device validation Width Height Depth Air flow/Pressure Drop leakage Volume Weight
Model NO. Time
mm mm mm m3/h/Pa IEST- 008 m3 kg
S
• Accurate testing results, avoid non-qualification for a sec- Laser particle counter or Photometer
ond test
CF-G-241212-101-AP 305 610 292 0.083 850/250 0.1% 0.05 18

• Strict performance test, reduce risk to minimum CF-G-242412-101-AP 610 610 292 0.083 1700/250 0.1% 0.11 37

• The global share of R & D, local operation support

Sampling fail Qualified Sampling

9 10