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TEK1/CLiMET

Date: 17 February 2016

We are pleased to submit proposal for words most rugged and consistent Microbial
Air Samplers manufactured by CLiMET Instruments, USA. CLiMET manufactures
three main models CI95, CI90 and CI99. CI95 is most popular among all models,
CI90 has a built in label printer and CI99 is a dedicated Insitu Air Sampler controlled
through software.
Biopharmaceutical Grade Design and Engineering
CLiMET microbial samplers are the only instrument on the market with a Validate
Flow Rate, audible Flow Rate Alarm and sample termination (LED and audible),
certified HEPA filtered exhaust to ISO Class 3, Stainless Steel enclosure that is VHP
compatible and autoclavable sample heads. Although there is no such thing as zerodefects, this unique technology eliminates deviation costs.
Mass Flow Controlled Sampler
The most important job of a microbial air sampler is to consistently sample 1000L of
air, sample after sample. To the best of our knowledge, CLiMET CI90, CI95 and CI99
are the only air samplers who have a MASS FLOW CONTROLLER built into the
instrument, which constantly measures the flow volume and adjusts and keep the
flow rate consistent at 100LPM. The ISO 14698 limits are +/- 5%. This flow control is
CLiMET patented.
Any flow rate changes, which are unknown, lead to lower or higher volume
sampling, which can completely put the CFU counting irrelevant. Under-Sampling
will leave the area to risk of unknown presence of microbial load in the area.

AccordingtoISO146981AnnexA.3.2,therearemanyfactorstoconsiderwhenchoosinganair
sampler.Theflowrate,durationofthesample,andtypeofsamplingcanstronglyinfluencethe
viabilityofthemicroorganismsthatarecollected.
ISO14698 Compliant
CLiMET CI90, CI95 and CI99 are fully compliant with ISO14698. Every air sampler
needs to be in compliance with ISO 14698 and should offer information on Biological
and Physical capturing efficiency. Unfortunately not every air sampler available in
the market has been tested to meet ISO14698 requirements. We have enclosed
CLiMET data for ISO14698.
Cost of deviation: Given the cost of a deviation report and investigation will likely
be around twice the cost of the microbial sampler, this will be a very expensive
alternative. This will be especially true if the end user has too scrap product
because the instrument is out of tolerance.

Exhaust Filter
Each CLiMET Air Sampler is fitted with exhaust filter. The CI90 is designed for low
particle emissions with filtered exhaust. Each unit is factory certified for low
emissions of better than ISO Class 3.
Built in Label Printer
For the purpose of traceability and records, CLiMET CI90 has a facility for printing
labels, which can be put on the petri dish and the physical records. Each label has
Unit ID, User ID, Location ID, Date, Time, Sample Volume and Sample Status: Ok/not
Ok
CLiMET Enclosures are SS not Plastic
CI90, CI95 and CI99 have SS enclosures.

WARNING - Plastic Enclosures: Contraryto

popularbeliefandvariousmarketingclaimsplasticenclosures,includingpolycarbonateandother
thermoplastic polymers are neither rugged nor durable. Plastic enclosures are prone to
damagefromimpact.Thisisespeciallytrueforhandheldorportableunits.
Thisdamagecantaketheformofinnocuouslittlescrapesorscratchesasshownabove.However,
thissameapparentlyharmlessscrapewhenviewedundermagnificationshowstherealdamage
andrisktocleanrooms
Plastic enclosure plastics have a VERY HIGH static charge that attracts particles of
all sizes. Plastics are particle magnets. This represents an increased biocontamination risk from particle carrying microbes.
Drop test:
Each instrument designed by Climet is rugged tested
- Instrument has a 1 meter drop tested ten times
- Instrument has a 1 hour vibration tested for one hour
- Final packaging drop tested 14 times (once on each side and on each corner of the
box)
If you drop the plastic air samplers and most other air samplers available in the
market will shatter!
Horizontal or Vertical Sampling
CI90 and CI95 can be kept upright or sideways, there are four legs on two sides for
horizontal sampling

Other benefits and support:

slot for mounting on tripod stand


100% of CLiMET air samplers are calibrated ONSITE by mk teknology1
CLiMET CI90 and CI95 have petri dish cover holder to hold the petri dish cover
during sampling

Multi-Functionality
Accessories are available for the CI-90A and CI-95A microbial samplers to allow it to
perform remote sampling in biological safety cabinets and isolators.
Additionally, accessories are also available that allow these instrument to monitor high
pressure gases, such as Nitrogen, CO2, etc.

Compressed Air/Nitrogen Sampling


CLiMET Air Samplers can be used for both room air sampling and compressed air
sampling. Compressed air can be sampled using the high pressure diffuser
Remote Microbial Sampling
CI90 or CI95 can also be configured for remote sampling. Most air samples do not
have option for remote sampling,
which often used in BSCs (Best Practices).

Microbial Samplers CLiMET Competitive Advantages


Operational Quality

Biological and Physical Collection Efficiency have been fully validated to ISO 146981. We compared our instrument against what we consider to be the gold standard in
biological efficiency.
The CI-9xA Series was tested against the SKC BioSampler, which is a glass
impingement sampler known in academic and industry circles to have excellent
collection efficiency of near 100% at a size of 1m or larger.
However, since the SKC BioSampler is made of glass it is not conducive for use with
industrial biopharma production. Moreover, the SKC BioSampler is very labor
intensive. It has a flow rate of only 12.5 LPM, and would take 80 minutes to sample
what the CI-9xA Series can do in 10 minutes.
The study was conducted by the Antimicrobial Test Lab (ATL), wherein ten samples
were taken from both the SKC BioSampler, and a CI-95A. In accordance with the ISO
14698-1 standard, the sample counts from the CI-95A were compared against the
SKC BioSampler, and Climet achieved a Sampling Efficiency or perhaps best
described as a Comparative Efficiency of 101.4%.
We next calculated the Correlation Coefficient, which is a statistical measure to
determine the linear relationship between to datasets. This additional step well
exceeds the ISO 14698-1 standard, and in laymans terms measures the variance
between our instruments sample count, and the SKC BioSampler. The Correlation
Coefficient between Climets CI-95A and the SKC BioSampler was 0.9681. This is
defined in statistical terms as, A near perfect positive linear relationship.
What this means to our customers is a much higher assurance of the accuracy,
repeatability, and reliability of the CI-9xA Series.
Cost of Poor Quality and ROI

In manufacture for a decade, Climet has yet to identify a single microbial CI-9x
Series sampler that has failed an interval calibration.
rd
Our factory experience was confirmed in a 2015 study among 3
party
independent calibration service providers. In a study consisting of over 2,500
calibrations the CI-9x microbial sampler (n= 404) was the only sampler NOT to have
any interval calibration out-of-tolerance (OOT) conditions. The other microbial
samplers ranged between 6.2 percent to 14.9 percent out-of- tolerance.
This is EXTREMELY important in biopharmaceutical manufacturing applications as
the cost of a single deviation or simple failure investigation averages between
$5,000 to $12,000. This hidden cost is almost all labor, and is difficult to calculate
as it usually involves multiple departments. Essentially, the cost of a single OOT will
typically far exceed the initial purchase price of a microbial sampler.

Quotation for CLiMET Microbial Air Samplers with facility for COMPRESSED
AIR/Nitrogen and Remote Microbial SAMPLING
S.
Description
Unit Qt Discoun Amoun
No
ted Unit
Price in y
t in
.
Price
in
US$
US$
US$

01 950090002

$ 01
6,642.0
0

02 950090102

$
7,504.0
0

CI-90A100LPMMicrobial Air Sampler


VHP Compatible Microbial Sampler for aseptic
cleanrooms and similar environments.
Included with each new unit is an internal thermal
label printer, internal battery charger, battery,
stainless steel locking collar, anodized aluminium
sample head autoclavable @134 deg C for 20
miniutes, two rolls of adhesive labels, IQ/OQ docs,
manual, ID Loader Software and AC power adapter.

CI-90A+100LPMMicrobial Air Sampler


VHP Compatible Microbial Sampler for aseptic
cleanrooms and similar environments.
Included with each new unit is an internal thermal
label printer, internal battery charger, battery,
stainless steel locking collar, anodized SS316
sample head autoclavable @134 deg C for 20
miniutes, two rolls of adhesive labels, IQ/OQ docs,
manual, ID Loader Software and AC power adapter.
CI-95A
25 LPM, 1CFM, or 100 LPM Microbial Air Sampler

Our Most Popular Unit


VHP Compatible Microbial Sampler for aseptic
cleanrooms and similar environments.
Included with each new unit is an internal battery
charger, battery, stainless steel locking collar,
sample head, IQ/OQ docs, manual, ID Loader
Software, and AC power adapter.
Supports Sample Segmentation. Users can sample
a cubic meter in one sample, or segment a cubic
meter over a user-specified period of time.
Configuration 950095-XYZ
Where X = Sample Head
0 = Alum, 90mm petri dish, 100 LPM(CI-A904)
Order#: 01210100
1 = S. Steel, 90mm petri dish, 100 LPM (CI-S904)
Order#: 01210103
4 = Alum, 90mm petri dish, 1 CFM /25 LPM
(CI-A901) Order#: 01210106
5* = S. Steel, 90mm petri dish, 1 CFM/25 LPM
(CI-S901) Order#: TBD
8 = Alum, 55-65 mm RODAC plate, 100 LPM
(CI-A604) Order#: 01210107
9* = S. Steel, 55-65mm RODAC plate, 100 LPM
(CI-S604) Order#: TBD
* This sample head is non-standard product. May
be
subject to extended lead time. Please contact us.
Where Y = Flow Rate
0 = 100 LPM 1 = 1 CFM2 = 25 LPM
Where Z = Power Supply Type
1 = United States2 = European Union 3 = United
Kingdom

03 CI-95A
P/N: 950095XYZPrice Includes Any Aluminum
Sample Head

$5,646.
00

04 CI-95A+
P/N: 950095XYZPrice Includes Any Stainless
Steel Sample Head
ACESSORRIES FOR REMOTE SAMPLING

$6,496.
00

05 01245011 Stainless Steel Sample AssemblySide Port


(this is the part that has the remote collar and
holds the petri dish).
06 01245111 Stainless Steel remote sample
assembly-bottom Port (this is the part that has
the remote collar and holds the petri dish).

$1,466.
00
$
1,688.0
0

07 01210104 Aluminum Remote Adaptor Head


08 73306100 Silicon braided tubing
(Autoclavable)
ACESSORRIES FOR COMPRESSD AIR
SAMPLING
09 01210109 Aluminium High Pressure Diffuser
Adaptor Head Compressed air sampling head
Freight/Insurance to New
Delhi/Mumbai/Hyderabad airport
Nett CIP New Delhi/Hyderabad/Mumbai Airport

$562.0
0
$31/Fo
ot
$1,160.
00
(Appro
x.)

$600.0
00

Terms & Conditions:


1. Make: CLiMET Instruments Company, 1320 W. Colton Ave. Redlands CA 92374,
USA
2. Price: CIF New Delhi/Hyderabad/Mumbai Airport
3. Payment: Through advance Wire Transfer.
4. Delivery: Within 8 weeks from receipt of an acceptable order and advance by
CLiMET Instruments Company.
5. Warranty: 12 months
6. Orders to be placed on: CLiMET Instruments Company, 1320 W. Colton Ave.
Redlands CA 92374, USA
Please send the PO to m k teknology1 Pvt. Ltd., GG-1, 139-C, PVR Road,
Vikaspuri, New Delhi-11018 India
Email: sanjaymiglani@teknology1.com M: +91 9810550075
7. Validity: 30 days from the date of offer.
Should you require further information or clarification, if any, please do not hesitate
to contact us.
Thanking and assuring you our best services at all the times
Yours Sincerely,
For m k teknology1 Pvt Ltd.
Sanjay Miglani
Director

TEK1/CLiMET
Date: February 19, 2016
TEKNOLOGY1 HIGH PRESSURE DIFFUSER FOR Compressed Air SamplingViable & Non Viable and accessories for remote monitoring
S.
Description
DRL
Qt Amount
N
Unit Price y
in INR
o.
INR
01 High Pressure Gas Diffuser for Compressed Air and
Rs. 01
Rs.
85,000.00
85,000.0
Nitrogen Sampling
0
RANGE: 40140 psig, FITTINGS: Inlet
Swagelok fitting, male or direct
input to standard compressed air
tubings
Outlet inch tapered tube
connection directly to Special sampling
head
Devices directly adaptable to the High
Pressure diffuser, High Pressure
Diffuser directly adaptable to the
compressed air source
No manual adjustment of flow rates
required, Easy to carry by single person, no
complicated fixtures involved
02 Accessories for Remote sampling
Rs. 01 Rs.
165,000.0 se 165,000.
SS valves- 3 Nos.
0 t
00
SS tubing network- 12 to 15 ft for three
sampling locations
(Customer can also use their SS fabricator for this
job)
Terms & Conditions:
Price
: Ex Works Delhi. Freight & Insurance extra @ 2% extra
Taxes
:
CST @2% against form C extra or as applicable. All Govt. taxes
extra.
Payment
: 100% advance along with order
Delivery
: 8 weeks from the date of an acceptable order and advance
Installation : Self-installable. Installation charges Rs. 10,000 + service tax
extra
Warranty
: 12 months from the date of dispatch.
Validity
: Validity of quotation 30 Days
If you have any questions regarding any of the above please feel free to contact us.
Thanking and assuring you our best services at all the times

Yours Sincerely,
For mk teknology1 Pvt. Ltd.
Sanjay Miglani
Director 9810550075 sanjaymiglani@teknology1.com

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