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Manufacturing Chemist 2-16-18

By | News

Certus starts manufacture of novel in-house pathogen detection system

New Certus System Detection Unit is designed to bring small and mid-sized food processing plants one step closer to a fast, easy and cost-effective way to detect pathogens.

The Certus System Detection Unit is an entirely in-house system, enabling food producers to perform environmental monitoring without the need for outsourced testing. The system is based on SERS nanoparticle technology made available through an exclusive license agreement with global medical technology organisation, Becton, Dickinson & Company.

With the commencement of manufacturing, the Certus System Detection Unit is on track for market availability in June 2018.

Manufacturing of the Detection Unit is being carried out at Certus’ parent company and precision manufacturer Toho Technology.

Founded in 1819 in Nagoya, Japan, Toho is a privately-held company that provides engineering, manufacture, distribution and support of diverse industrial and life-science technologies to customers around the world.

With a well-established global market presence in optical instrumentation in the fields of semiconductor, flat panel display and process engineering, Certus leverages the Toho team and talent to advance from R&D into full scale commercial production.

“Being part of the Toho Technology family provides us with a myriad of technological and commercial benefits to ensure our products exceed the market’s expectations for precision and accuracy,” said Certus Director of Product Development, Dr John Bodner.

“Not only does Toho provide significant expertise in the manufacture of precision instrumentation, they also provide Certus with the solid infrastructure and financial backing needed to bring this level of innovation to our customers.”

In addition to partnering with Toho, Certus works with UK-based Solus Scientific for assay development.

“One of the reasons we chose to partner with Solus is because of their efficient research and development track record on bringing to market a range of assays in the area of food safety testing,” said Bodner.

The Certus Listeria El assay was developed in collaboration with Solus in 2017, while the environmental Salmonella assay is currently under development and expected to be available for use in the Certus System in Q4 of this year.

“Through BD’s exclusive license to Certus and our strategic partnerships with Toho and Solus, we can ensure best-in-class products for our clients, with the end goal of removing the most harmful pathogens from the food system,” said Bodner.

The Certus System will be commercially available in June 2018 and will feature a simple workflow, Bio-Lock safety components and real-time monitoring for rapid results.

Full Article

Cleanroom Technology 2-16-18

By | News

Certus starts manufacture of novel in-house pathogen detection system

New Certus System Detection Unit is designed to bring small and mid-sized food processing plants one step closer to a fast, easy and cost-effective way to detect pathogens.

The Certus System Detection Unit is an entirely in-house system, enabling food producers to perform environmental monitoring without the need for outsourced testing. The system is based on SERS nanoparticle technology made available through an exclusive license agreement with global medical technology organisation, Becton, Dickinson & Company.

With the commencement of manufacturing, the Certus System Detection Unit is on track for market availability in June 2018.

Manufacturing of the Detection Unit is being carried out at Certus’ parent company and precision manufacturer Toho Technology.

Founded in 1819 in Nagoya, Japan, Toho is a privately-held company that provides engineering, manufacture, distribution and support of diverse industrial and life-science technologies to customers around the world.

With a well-established global market presence in optical instrumentation in the fields of semiconductor, flat panel display and process engineering, Certus leverages the Toho team and talent to advance from R&D into full scale commercial production.

“Being part of the Toho Technology family provides us with a myriad of technological and commercial benefits to ensure our products exceed the market’s expectations for precision and accuracy,” said Certus Director of Product Development, Dr John Bodner.

“Not only does Toho provide significant expertise in the manufacture of precision instrumentation, they also provide Certus with the solid infrastructure and financial backing needed to bring this level of innovation to our customers.”

In addition to partnering with Toho, Certus works with UK-based Solus Scientific for assay development.

“One of the reasons we chose to partner with Solus is because of their efficient research and development track record on bringing to market a range of assays in the area of food safety testing,” said Bodner.

The Certus Listeria El assay was developed in collaboration with Solus in 2017, while the environmental Salmonella assay is currently under development and expected to be available for use in the Certus System in Q4 of this year.

“Through BD’s exclusive license to Certus and our strategic partnerships with Toho and Solus, we can ensure best-in-class products for our clients, with the end goal of removing the most harmful pathogens from the food system,” said Bodner.

 

The Certus System will be commercially available in June 2018 and will feature a simple workflow, Bio-Lock safety components and real-time monitoring for rapid results.

Full Article

Press Release 2.13.18

By | Press

 

CERTUS Begins Manufacturing of Novel In-House Pathogen Detection System with Toho Technology

Food safety innovators on track for Q2/2018 market availability for small and mid-sized processing plants

CHICAGO – February 13, 2018 – CERTUS, innovators in food safety technologies, has begun manufacturing of the CERTUS System Detection Unit, bringing small and mid-sized food processing plants one step closer to a fast, easy and cost-effective way to detect pathogens. Based on SERS nanoparticle technology made available through an exclusive license agreement with BD (Becton, Dickinson and Company), a leading global medical technology company, the CERTUS System is an entirely in-house system, enabling food producers to perform environmental monitoring without the need for outsourced testing. With the commencement of manufacturing, the CERTUS System Detection Unit is on track for market availability in June 2018.

Toho engineer makes final adjustments on CERTUS Detection Unit.

Manufacturing of the Detection Unit is being carried out at CERTUS’ parent company and iconic precision manufacturer Toho Technology. Founded in 1819 in Nagoya, Japan, Toho is a privately-held company that provides engineering, manufacture, distribution, and support of diverse industrial and life-science technologies to customers around the world.  With a well-established global market presence in optical instrumentation in the fields of semiconductor, flat panel display, and process engineering, CERTUS leverages the Toho team and talent to advance out of R&D and into full-scale commercial production.

“Being part of the Toho Technology family provides us with a myriad of technological and commercial benefits to ensure our products exceed the market’s expectations for precision and accuracy,” said CERTUS Director of Product Development, Dr. John Bodner. “Not only does Toho provide significant expertise in the manufacture of precision instrumentation, they also provide CERTUS with the solid infrastructure and financial backing needed to bring this level of innovation to our customers.”

In addition to partnering with Toho, CERTUS works with United Kingdom-based Solus Scientific for assay development. “One of the reasons we chose to partner with Solus is because of their efficient research and development track record on bringing to market a range of assays in the area of food safety testing,” continued Bodner.

The CERTUS Listeria El assay was developed in collaboration with Solus in 2017, while the environmental Salmonella assay is currently under development and expected to be available for use in the CERTUS System as early as Q4 of this year.

“Through BD’s exclusive license to CERTUS and our strategic partnerships with Toho and Solus, we can ensure best-in-class products for our clients, with the end goal of removing the most harmful pathogens from the food system,” said Bodner.

The CERTUS System will be commercially available in June 2018 and will feature a simple workflow, Bio-Lock™ safety components and real-time monitoring for rapid results. For more information on CERTUS visit certusfoodsafety.com.

ABOUT CERTUS™

CERTUS changes the way food safety testing is done and helps reduce food-borne illness with a new generation of food pathogen detection devices and processes that are precise, affordable and easy to use.  Making rapid pathogen detection and prevention Simple, Safe and Smart, CERTUS is built on the foundations of empowerment, simplicity, precision, and integrity.  CERTUS seeks to integrate historically embraced values into future technology to bring innovation and expansive vision to the food safety industry.  CERTUS joins the Toho Technology group of companies as a new brand specializing in Food Safety.  Founded in 1819 in Nagoya, Japan, Toho is a privately-held company that provides engineering, manufacture, distribution, and support of diverse industrial and life-science technologies to customers around the world.  With significant expertise in precision instrumentation and equipment sales, Toho Technology advances the way products are made, tested and verified within the fields of food safety, healthcare, and nanotechnologies. The company currently operates multiple facilities in Chicago, Illinois; Japan; Shanghai, China, and Jakarta, Indonesia. Toho Technology Inc. is the launch site for the CERTUS global expansion with all R&D, operations and sales centered in its Chicago location.

To learn more, visit certusfoodsafety.com or call us at 872-810-4123.

Full Article

Crafting a Recall Plan

By | Blog

When Prevention isn’t Enough, a Carefully Crafted Recall Plan Goes into Effect

Your food safety plan should include a recall plan for each food with a hazard requiring a preventive control. According to the FDA, you must establish a written recall plan which must include procedures that describe the steps to be taken, and assign responsibility for taking those steps.

Notify the Buyer

Notify the direct consignees of the food being recalled, including how to return or dispose of the affected food.

Go Public

Notify the public about any hazard presented by the food when appropriate to protect public health.

Verify

Conduct effectiveness checks to verify that the recall is carried out.

Dispose

Appropriately dispose of recalled food. Possible disposal methods include:

Reprocessing

Reworking

Diverting to a use that does not present a safety concern

Destroying the food

For more information about recall plans, read the Federal Code of Regulations.

The National Provisioner 1-30-18

By | News

CERTUS to bring in-house salmonella testing to food processing plants

CERTUS, innovators in food safety technologies, announced the expansion of its rapid food pathogen detection menu with the initiation of research and development of an Environmental Salmonella assay. To address a pathogen which, according to the CDC causes more than one million food-borne illnesses in the United States annually, the new CERTUS Salmonella test will use the same proprietary Surface Enhanced Raman Spectroscopy (SERS) technology and instrument platform as the company’s CERTUS EL test for Listeria, which is due to launch in early 2018. End-use benefits will similarly include extremely simple workflow, on-site testing capabilities, real-time growth monitoring, immediate alerts upon detection and bio-containment for the safety of the food processor and consumer. As with the CERTUS Listeria assay, the Salmonella test will be, “All-in one, all in-house.”

“CERTUS remains committed to developing tools to help food producers protect consumers from the world’s most dangerous pathogens,” says CERTUS President, John Coomes. “Salmonella continues to plague the food industry in large numbers, so we’re excited to develop an in-house solution for small and mid-sized food processing plants and address a true need in the market. Our customers will realize greater value with the CERTUS system now that they will be able to run both environmental Listeria and Salmonella in the same instrument.”

As with the CERTUS EL test, the CERTUS Salmonella assay is being designed to run in a single enrichment media, homogeneous no wash format. This means that no sample manipulation is required and that the assay tube never has to be opened once the sampling swab is inserted. The assay will be delivered in a Bio-Lock™ tube/cap design that cannot be opened after enrichment begins thus securing the environment from accidental contamination. This feature, combined with the target time-to-result goal of less than 24 hours, enables food producers to move testing on-site for significantly faster results.

Reagent research and development is being conducted in collaboration with CERTUS research partner, Solus Scientific, a UK-based food pathogen assay developer. Solus Scientific is the developer and manufacturer of their own Listeria, Salmonella and E. coli ELISA designed for large volume sample processing. Solus is also the assay development partner for the CERTUS EL assay used in the CERTUS System which is currently seeking AOAC validation.

For more information, visit http://CertusFoodSafety.com.

Full Article

Taking a Look at Preventive Controls

By | Blog

Preventive Controls are a Necessary Component of Your Food Safety Plan

When developing your food safety plan, you must specify controls to ensure that identified hazards will be minimized or prevented. Preventive controls may include controls for processes, food allergens, and sanitation, as well as supply-chain safety, and a recall plan. The types of preventive controls you use will depend on the facility and the food:

Process Controls

Process controls are the procedures, practices, and processes to ensure the control of operations such as heat processing, acidifying, irradiating, and refrigerating foods.

Food Allergen Controls

Food allergen controls are the procedures for ensuring protection of food from allergen cross-contact (preventing the unintentional incorporation of an allergen in a food) — including during storage, handling, and use — and correctly labeling the finished food if it contains any of the eight major food allergens:

Milk

Eggs

Fish

Crustacean shellfish

Tree nuts

Peanuts

Wheat

Soybeans

Sanitation Controls

Sanitation controls are the procedures to ensure the facility’s sanitation practices are adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must address:

Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment

Prevention of allergen cross-contact

Cross-contamination from insanitary objects

Cross-contamination from personnel to food, food packaging material, and other food-contact surfaces;

Cross-contamination from raw product to processed product

Note that sanitation controls do not include all sanitation procedures used in the facility, only those that are used to control hazards.

Supply Chain Controls

Supply-chain controls are activities taken to verify that suppliers that are controlling hazards are doing so effectively.

Recall Plan

A recall plan is necessary for any food with a hazard requiring a preventive control. It must be written and must include steps to take (and who is responsible for taking them) to

Notify your direct customers

Notify the public, if necessary

Check the effectiveness of the recall

Dispose of the food appropriately.

For more information on Preventive Controls, read the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Prevent Contamination in your Food Processing Plant

By | Blog

Supervisors and Personnel Share Responsibility for Keeping Plant Free from Contamination

To limit the potential for contamination, plant management should take all reasonable measures and precautions to ensure that personnel who are involved in food processing are healthy and conduct adequate hygiene and cleanliness.

Disease Control

If a supervisor observes any person appearing to have an illness, open lesion, boils, sores, infected wounds, or any other abnormal source of microbial contamination and there is a reasonable possibility of contaminating food, food-contact surfaces, or food-packaging materials, the supervisor shall exclude this person from any operations which may be expected to result in such contamination until the condition is corrected. Additionally, personnel should be instructed to report such health conditions to their supervisors.

Cleanliness

All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:

Clothing

Wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials.

Hygiene

Maintain adequate personal cleanliness.

Hand Washing

Wash hands thoroughly (and sanitize if necessary) in an adequate hand-washing facility:

Before starting work

After each absence from the work-station

At any other time when the hands may have become soiled or contaminated

Accessories

Remove all unsecured jewelry and other objects that might fall into food, equipment, or containers, and remove hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.

Gloves

Maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.

Hair

Wear, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.

Personal Belongings

Store clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.

Behaviors

Confine the following to areas other than where food may be exposed or where equipment or utensils are washed:

Eating food

Chewing gum

Drinking beverages

Using tobacco.

Additional Precautions

Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to:

Perspiration

Hair

Cosmetics

Tobacco

Chemicals

Medicines applied to the skin

 

For more information view the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food. 

 

The FDA Offers a Step-by-Step Guide to Build Your Food Safety Plan

By | Blog

Consolidated Resources and Step-by-Step Guidance to Develop a Personalized Food Safety Plan

Building your food safety plan can be a daunting task. The FDA provides a plan builder and other resources to help owners and operators of food facilities develop a personalized food defense plans for their facilities.

The Food Defense Plan Builder is a user-friendly software program that harnesses existing FDA tools, guidance, and resources for food defense into one single application.

The Food Defense Plan Builder guides the user through the following sections:

  • Company Information
  • Broad Mitigation Strategies
  • Vulnerability Assessment
  • Focused Mitigation Strategies
  • Emergency Contacts
  • Action Plan
  • Supporting Documents

Ready to get started?

Food Defense Plan Builder

Learn More | Download Now | View System Requirements

Training Videos

Watch Now

Workshops

Check out what’s available

Need more? Visit the FDA website for more information and resources.