Bringing Microbiology to Light
Rapid Positive Release of
COMMERCIALLY
STERILE PRODUCTS
SIMPLE - FAST - ACCURATE
Rapid Positive Release of
COMMERCIALLY STERILE PRODUCTS
Manufacturers of dairy and plant-based Ultra High Temperature (UHT) and Extended Shelf
Life (ESL) products, can now release finished product faster with a more streamlined workflow How does it work?
using the Oculer Commercial Sterility Check (CS-Check) assay. The Oculer system
The reduced time to result leads to lower warehouse costs, plus early warning of possible spoilage uses a luminescent
problems thereby reducing waste production and enabling immediate root cause investigation. sensor to detect
In a fast moving, routine production facility, it is essential to have a simple to use check on oxygen depletion
commercially sterile products, one that is rapid and more accurate than traditional plates. caused by growth of
The Oculer CS-Check assay will automatically monitor and analyse samples, detecting the yeast and moulds in a
presence of microorganisms in as little as 24 hours compared to 72 hours on traditional plates. proprietary selective
Results are available in real-time leading to much faster alerts of positives.
medium, specifically
Using pre-prepared vials, stored at ambient temperature, the Oculer CS-Check assay, does formulated for this
not require a lab or specific microbiological expertise to achieve positive release on application.
commercially sterile finished products.
FAST EASY TO USE
Commercial sterility pass result One step sample inoculation into
within 48 hours after pre-incubation. ready-prepared vials, can be done by
any operative.
SENSITIVE FLEXIBLE
A larger sample size (10ml) is up Not affected by sample matrix, same
to 100 times more sensitive protocol can be used for dairy or
than plates. plant-based beverages.
FULLY AUTOMATED COST EFFECTIVE
Reduce manual errors; collect Releasing product faster lowers
real-time data without the need for warehousing need.
highly skilled staff.
Typical workflow
Traditional
Plate
Method
SEnd TO LaB PREP and add SaMPLES ManUaLLy PROdUCT RELEaSE
QC MEdIa TO PLaTES REad and 120 HOURS
RECORd RESULTS afTER PROdUCTIOn
Oculer
Yeast and
Mould Assay
add 10ml SaMPLE PROdUCT RELEaSE
TO OCULER VIaL aT OnLy 48 HOURS afTER
PROdUCTIOn LInE OR In LaB PROdUCTIOn
Simple - Fast - Accurate Suitable for UHT or ESL Beverages
• Protect brand with positive release • Milks
• not affected by opacity • yoghurts
• Same protocol for all products • flavoured milks
• automated alerts from multiple sites • dairy or plant-based
Oculer Ltd., Technopath Life Science Park, fort Henry, Ballina, Co. Tipperary, Ireland I [email protected] I Call us on + 353 61 525700
Bringing Microbiology to Light
Automated
YEAST AND MOULD DETECTION
in Less Than 48 Hours
SIMPLE - FAST - ACCURATE
Automated
YEAST AND MOULD DETECTION
in Less Than 48 Hours
Manufacturers of fruit-containing beverages and desserts such as fruit yoghurts, How does it work?
smoothies, juices and flavoured milks, can now release finished product faster
The Oculer system uses a
with the oculer yeast and Mould (y+M) assay. the reduced testing time leads
to lower warehousing costs, increased product shelf life; early warning of spoilage luminescent sensor to
problems can reduce product wastage. ideally suited to a fast moving, routine detect oxygen depletion
production facility, the oculer y+M assay will automatically monitor and analyse caused by growth of yeast
samples, detecting yeast and moulds in as little as 48 hours compared to 120 and moulds in a proprietary
hours on traditional plates. results are available in real-time leading to much selective medium,
faster notification of positives. using pre-prepared vials of media stored at specifically formulated for
ambient temperature, the oculer system does not require a lab or specific
this application.
microbiological expertise.
FAST EASY TO USE
Yeast and mould results within 48 hours One step sample inoculation into
reduces risk. Release product only after ready-prepared vials, can be done by
test results become available. line operatives on production floor.
SENSITIVE FLEXIBLE
A larger sample size (10ml) is up Not affected by sample matrix,
to 100 times more sensitive suitable for fruit-containing
than plates. beverages and desserts.
FULLY AUTOMATED COST EFFECTIVE
Reduce manual errors; collect Releasing product faster lowers
real-time data without the need for warehousing costs and maximises
highly skilled staff. shelf life.
Typical workflow
Traditional
Plate
Method
send to LaB PreP and add saMPLes ManuaLLy Product reLease
Qc Media to PLates read and 120 HOURS
record resuLts after Production
Oculer
Yeast and
Mould Assay
add 10ml saMPLe Product reLease
to ocuLer ViaL at onLy 48 HOURS after
Production Line or in LaB Production
Simple - Fast - Accurate Suitable for Fruit-Containing
Beverages and Desserts including:
• not affected by pulp or opacity • yoghurts
• same protocol for all products • smoothies
• Juices and concentrates
• automated alerts from multiple sites • flavoured Milks
• Protect your brand with positive release • dairy or Plant Based
oculer Ltd., technopath Life science Park, fort Henry, Ballina, co. tipperary, ireland i [email protected] i call us on + 353 61 525700
Oculer EM-Check® Surface Contamination Test
BENEFIT S
Time-to-Result
• Achieve results typically within 24 hours
• Increase sensitivity by maximising recovery
• Advanced test tracking and reliability
Cost Saving
• Easier disposal than agar plates
• No extra costs and risks due to reagent dispensing
• Reduces risks of false positives in aseptic
production areas and related investigations
Test Ready
• Fully prepared and disposable
• Minimizes operator handling
• Eliminates unintended contamination
Reduced Operator Handling
The Oculer EM-Check Surface Microbial Detection Kit is an all-inclusive, ready- • Decreases time-consuming and operator-
to-use kit which simplifies and quickens the process of environmental surface dependent manipulations
testing for biological contamination. The kit uses Oculer’s Rapid 930 Series • Simplified standard operating procedures
Technology for the automated detection of microbial activity on cleanroom • Faster sampling steps
surfaces using a design that reduces the likelihood of sample cross- • Easy lift-out interchangeable carousel
contamination and mishandling of samples by the operator. FEATURE S
The OC-ENV-02 kit is intended to be used with the Oculer 930 Series • Standard TSB culture media
automated reader. The reader’s internal LED sends light to the polymer • FLOQSwab™ flocked swab with SRK™ for highest
sensor located in the kit vial. The optical system detects the decay of the recovery swabbing (>70% each lot).
fluorescence signal emission, which correlates to the oxygen depletion over • Reduced variability on results
time due to the respiration of microorganisms in the sample. The system is • Eliminate cleaning validation studies for culture
media residues required for contact plate method
flexible and allows either enumeration produced from an internal
calibration, or a pass/fail test based on presence/absence of oxygen • Compact design and low maintenance reader
• Integrated incubator
depletion over time. The instrument software allows continuous
• Intuitive screen monitor
measurements of oxygen depletion within the reader or endpoint
• Easy-to-read dashboard with tabular graphics
measurements from externally incubated samples.
• Result as Presence/Absence or as colony forming
The OC-ENV-02 kit with Oculer’s dedicated reader offers: units (CFU)
• Secure results and 21 CFR part 11 and EU GMP
• A traditional, growth-based method with enhanced sensitivity due to the Annex 11 compliance
oxygen sensing technology • Compatible with Microsoft Windows 10®
• Non-destructive testing allows further analysis or speciation by traditional
methods APPLICATION S
• Suitability for Class A/ISO 5 classified areas and lower • Microbiological surface sampling in cleanrooms and
• An ideal way to sample the most critical and hard-to-reach points identified associated controlled environments
by risk assessment • Microbiological monitoring of equipment, operator
• High recovery of surface microbial contaminants using certified flocked clothing and gloves
swabs • Easy monitoring of critical point in RABS and
isolators
• Faster time-to-result by using an oxygen-sensitive probe assay
• Automated sample analysis eliminating human reading subjectivity
• Up to 24 samples can be automatically processed per carousel
Bringing Microbiology to Light
Oculer EM-Check® Surface Contamination Test
OC-ENV-06 Microbial Detection Kit - SPECIFICATIONS
Surface Detection Kit
Materials Each individual gamma irradiated peel pouch kit contains:
- EM-Check® Vial: polypropylene vial with integrated platinum porphyrin polymer and 10 ml of TSB
- FLOQSwab: flocked swab in polypropylene tube with sponge and 1ml of Surface Rinse Kit™ (SRK)
Dimensions EM-Check® Vial - 15 ml capacity vial: Swab tube:
- 120 mm length including red stopper - 175 mm total length including green stopper
- 17 mm diameter - 12 mm external diameter
Filling Volume 10 ml
Media Tryptic Soy Broth (TSB)
Additives Neutralizers included in the SRK buffer
Packaging Option Two bags containing five kits each are triple-bagged together, 20 of the triple-bagged units are placed
inside a fourth plastic bag to produce a final package containing a total of 200 vial kits.
Storage Temperature 5 °C - 25 °C (41 °F to 77 °F)
Approximate Detection 100 to 108 cells
Oculer Rapid 930 Series Automated Reader
Model Model 930-15 uses 15 ml Operating Temperature 18 °C to 24 °C (64.4 °F to 75.2 °F)
capacity vials or adapters
Test capacity 24 vials Storage Temperature 10 °C to 35 °C (50 °F to 95 °F)
Throughput Up to 216 tests in pass/fail mode Relative Humidity 0 - 95% non-condensing
Power (adaptor supplied) 100-240 VAC, 50-60 Hz Dimensions (H x W x D) 31.8 x 30.50 x 38.14 cm
Output 72 W max (12.52 x 12.01 x 15.02 in)
USB ports 1 USB peripheral port Weight 12.30 kg (27.12 lbs)
1 external Barcode Reader port
Internal Incubation Ambient 2 °C to 40 °C Accessories Laptop computer (pre-loaded
Temperature (35.6 °F to 104 °F) with Oculer software), extra
carousel (24 places), external
Language Manageable by end-user Barcode Reader
The OCUSwab™ vial uses Oculer Rapid 930 Series® Technology; Rapid 930 Series ® is a registered trademark of Oculer Ltd.
FLOQSwab™ and Surface Rinse Kit™ (SRK) are trademarks of COPAN Diagnostics Inc.
Windows 10® is a registered trademark of Microsoft Inc.
All other trademarks are the property of their respective company.
Oculer Ltd reserves the right to change specifications without notice.
© 2022 Oculer Limited. All rights reserved.
Automated Yeast and
Mould Detection in less
than 48 hours
Manufacturers with Yeast and Mould
concerns can now release finished product
faster with the Oculer Yeast and Mould
(Y&M) assay.
Oculer’s proprietary selective medium
encourages the growth of yeast and mould
while suppressing the growth of bacteria,
even in live yoghurt.
The reduced testing time leads to lower warehousing costs and increased product shelf life as early warning
of spoilage problems can reduce product wastage. Ideally suited to a fast moving, routine production facility.
FAST EASY TO USE
Commercial sterility pass One step sample inoculation
result within 48 hours after into ready-prepared vials, can
pre-incubation be done by any operative
SENSITIVE FLEXIBLE
A larger sample size (10mm) is Not affected by sample matrix,
up to 100x more sensitive than same protocol can be used for
plates airy or plant-based beverages
FULLY AUTOMATED COST EFFECTIVE
Reduce manual errors; collect Releasing product faster
real-time data without the lowers warehousing costs
need for highly skilled staff and maximises shelf life
How it works
The Oculer Y&M assay will automatically monitor and uses dedicated APCheck® vials that are pre-filled with
analyse samples, detecting yeast and moulds within hours, bioengineered media, gamma-irradiated to guarantee
with a confirmed negative result for a 10 ml sample within 48 sterility, and which are validated to be stored for extended
hours compared to 120 hours on traditional plates. The 10 ml periods at ambient temperature. The Oculer system does not
sample size gives a minimum tenfold increase in sensitivity require a lab or specific microbiological expertise. APCheck®
over traditional methods. vials are delivered following rigorous quality assurance tests,
Results are available in real-time, often leading to much faster removing the need for on-site media production and
notification of positives. The Oculer Rapid 930 Series system associated quality control.
Typical Applications for Yeast & Mould Assay
UHT dairy and plant Fresh and pasteurised Alcohol-free beers Yoghurt and cream
based products fruit juices and wines
Faster than plates More sensitive Eliminate media Assays per instrument
preparation
Simple - Fast - Accurate Suitable for UHT or ESL Beverages
• Protected brand with positive releas • Milks
• Not affected opacity • Yoghurts
• Same protocol for all products • Flavoured milks
• Automated alerts from multiple sites • Dairy or plant-based
Improve your cashflow and protect your brand with Oculer.
Contact us today for a proof of concept discussion.
Oculer Ltd, Unit 2 Shannonside Business Park, Birdhill, Co. Tipperary, V94 5K02 +353 (0)61 525 700 www.oculer.com
[email protected]
Rapid Positive Release of
Commercially Sterile
Products
The Oculer CS-Check® is an automated
commercial sterility testing system for
a wide range of products including Dairy,
Non-Dairy and carbonated beverages.
The reduced time to result leads to lower warehouse costs, plus early warning of possible spoilage problems
thereby reducing waste production and enabling immediate root cause investigation. In a fast moving,
routine production facility, it is essential to have a simple-to-use check on commercially sterile products,
one that is rapid and more accurate than traditional plates.
FAST EASY TO USE
Commercial sterility pass One step sample inoculation
result within 48 hours after into ready-prepared vials, can
pre-incubation be done by any operative
SENSITIVE FLEXIBLE
A larger sample size (10mm) is Not affected by sample matrix,
up to 100x more sensitive than same protocol can be used for
plates airy or plant-based beverages
FULLY AUTOMATED COST EFFECTIVE
Reduce manual errors; collect Releasing product faster
real-time data without the lowers warehousing costs
need for highly skilled staff and maximises shelf life
How it works
The Oculer CS-Check assay will automatically monitor enhancement in sensitivity by several orders of magnitude.
and analyse samples, detecting the presence of The presence of bacteria, yeasts and moulds is accomplished
microorganisms within minutes, with a confirmed negative in a single test.
result in 48 hours. Results are available in real-time leading to
much faster alerts of positives. Unlike ATP and flow cytometry Using gamma-irradiated, pre-prepared vials, stored at
tests, the Oculer system utilises a 10 ml sample volume which ambient temperature, the Oculer CS-Check® assay, does not
enables the system to detect bacteria and yeast & moulds require a lab or specific microbiological expertise to achieve
down to a single organism. This represents a breakthrough positive release on commercially sterile finished products.
More sensitive Faster than agar Independently For early results
validated inclusivity
Simple Fast Accurate
• Protected brand with positive releas
• Not affected opacity
• Same protocol for all products
• Automated alerts from multiple sites
Suitable for UHT or ESL Beverages
• Milks
• Yoghurts
• Flavoured milks
• Dairy or plant-based
Improve your cashflow and protect your brand with Oculer.
Contact us today for a proof of concept discussion.
Oculer Ltd, Unit 2 Shannonside Business Park, Birdhill, Co. Tipperary, V94 5K02 +353 (0)61 525 700 www.oculer.com
[email protected]
