Klaratech

YOUR PROCESS AUTHORITY IN THE HEART OF EUROPE

Aseptic processing and packaging

Aseptic processing and packaging validation services. 

Sterilization evaluation and process establishment. 

We offer validation audits and spoilage investigations.

In-Container sterilization

Thermal process development for low acid, acid or acidified products packed in any type of container. We validate all kind of sterilizers. 

    

Exporting

to the us

We assist with FDA filings and facility registration, covering all technical compliance services and regulatory requirements. 

We offer support with FDA detention issues, import alerts and inspection reports

Standards

& regulations

FSMA's Preventive Controls Rule, by FSPCA PCQI lead instructor.

Foreign Supplier Verification Program (FSVP), HACCP, GMP/SSOP, allergens, sanitation and label compliance.

Third party audits.

TRAINING

Get trained with the experts!!!

All our professionals are highly recognized specialists in their fields. Thermal processing workshops. 

Hands-on training upon demand

Customized classes.

English, Spanish or Italian. 

Aseptic Processing and Packaging

  • Aseptic processing and packaging system audits.

  • Sterilization evaluation and process establishment

  • Compliance audits for sterilization, filling and packaging systems

  • Process deviation evaluation

  • Evaluation and selection of equipment & packaging suppliers

  • Validation services

  • Spoilage investigations

  • Pre-purchase consultation

  • New technology implementation & regulatory acceptance

 

In-Container Sterilization

Validation for all systems:

  • Low acid, high acid and acidified products

  • Packed in rigid, semi-rigid and flexible containers, including pouches, trays and glass.

  • Processed in steam, water spray, water cascade, water immersion sterilizers (static/agitated), continuous rotary and hydrostatic sterilizers

System evaluation and process establishment:

 
 

Assistance with export to the US

Services for exporting to the US

  • US FDA filings and facility registration

  • US FDA import detention issues

  • US FDA inspection reports

  • Third party audits

  • Process deviation evaluation for US-FDA compliance

  • US FDA filing and facility registration

    Filing products with the FDA for export to the US FDA involves much more than filling out forms. Technical compliance of  your aseptic  processing and packaging system must be demonstrated throughout a third-party audit. Our professionals have 30+ years of experience in the field. Let us help you making the journey throughout US exports a smooth one! 

  • US FDA import detention and import alerts

    We offer assistance when FDA issues a notice of detention that stops the product from entering the US. Detentions happen whenever a product seems to violate FDA regulations. Product detentions are costly and could damage the company reputation if not handled fast and properly.

     

    When FDA issues an import alert, the product is automatically detained. To remove an import alert, the processor must send to FDA proof that the product complies with FDA regulations. This process can be long and costly.

  • Deviation handling

    Process deviations often occur in every processing plant. Appropriate handling of the product and disposition determination can be a real headache. Let us help you with that!

    By reviewing the processing deviation documentation, making calculations, and occasionally performing further testing, we can determine the appropriate product disposition.

    We also write the process deviation letters, which are mandatory for any product for the US market that undergoes a process deviation.

 

Standards & Regulations

  • Assistance with implementation of FSMA’s Preventive Controls Rule, by FSPCA PCQI (Preventive Controls Qualified Individual) lead instructor.

  • Preventive controls

  • Foreign Supplier Verification Program (FSVP)

  • Complementary regulations of the Title 21 CFR

  • Bioterrorism / US Foreign Facility Registrations

  • Labeling regulations

  • Assistance with nutritional & allergen labeling information

  • HACCP, GMP/SSOP & Food Defense Plan Development, Implementation or Review.

  • Third party audits on GMPs, allergens, sanitation and label compliance.

Training

Get trained by the experts!

  • Courses can be combined and customized according to customer's equipment and operation

  • Hands-on training available upon demand

  • Classes can be offered at customer's site. 

  • Process optimization method’s theory and application training (applied to customer’s own data evaluation)

  • Trilingual:  English, Spanish or Italian

Our team

  • Clara Rovedo

    Clara Rovedo PhD is a thermal processing specialist and internationally recognized Process Authority.

    She has a Chemical Engineering degree from Universidad Nacional de Mar del Plata (Argentina) and a PhD in Chemistry from Universidad de Buenos Aires (UBA, Argentina).
    She was awarded the Universidad de Buenos Aires Scholarship for Graduate Students to pursue her PhD.  She also obtained the prestigious CONICET (Argentina's Research Council) Fellowship for Studies Abroad, for post-doctoral research at UCDavis (USA). She has published several articles, book chapters and more than 30 presentations at international meetings about heat and mass transfer.
    Since 2000, Clara worked as a recognized thermal process authority by FDA for customers worldwide.  She traveled extensively along North, Central, South America, and Europe, conducting thermal processing studies, process design, equipment audits, and teaching thermal processing courses in English and Spanish. Clara is proficient in state-of-the-art thermal processing software, analysis of data, process design and deviations, for compliance with FDA/USDA regulations.  

    In 2012, she started KlaraTech as a freelance thermal processing and food safety consultant.

  • Stephen Spinak

    Stephen H. Spinak is an aseptic processing and packaging expert, a thermal process engineer and international consultant.

    He received his B.S. and M.S. degrees in Food Science from the University of Maryland, College Park, Maryland. From 1974 to 1976, he served as a thermal processing engineer with the National Canners Association (now known as the Grocery Manufacturers Association).   He worked as food technologist with FDA's Division of Food Technology from 1977 to 1980, and with the USDA, Food Safety and Inspection Service from 1980 to 1991. At USDA, Stephen served as the National Field Coordinator for its HACCP development project.  He worked for the FDA’s Center for Food Safety and Applied Nutrition for 15 years (1991 – 2006), as project manager for FDA's International Cannery Inspection Program and for Filing and Evaluation of Thermal Processes for Acidified and Low-Acid Canned Foods (LACF). He participated as an Official of the U.S. Delegation to the Codex Committee on Food Hygiene for 17 years and he was chairman of the Codex Aseptic Processing and Packaging Work Group.  He was the primary developer of the USDA FSIS's Canning Training program in the ‘80s and the USDA FSIS's LACF Train the Trainer Program in 2008. He participated in the development of FDA's Basic Canning Course, Advanced Canning Course and Aseptic Processing and Packaging Course during his time with FDA.  He also developed several LACF capacity building projects for FDA in South America.  In 2006, after retiring from FDA, Stephen started Spinak Consulting LLC, a highly recognized process authority in the field of aseptic and in-container thermal processing. He assists plants located worldwide and importers with thermal process projects and FDA filings.

  • Guido Moruzzi

    Guido received his Master of Science degree in Industrial Chemistry in 1979 from the Alma Mater Studiorum (University of Bologna). He is now retired after 38 years working in the industry, 35 of which he worked in Tetra Pak in Research and Development on aseptic filling systems for liquid food products. From 2002 until his retirement he had the role of Company Specialist, Aseptic Technology. Guido’s experience ranges from development of sterilization technologies in aseptic filling machines, to validation of aseptic fillers and filing with the FDA, to evaluation of quality of aseptic production lines at food processing plants. He is the inventor of the UV-Hydrogen Peroxide process currently used in Tetra Pak’s high-speed aseptic filling machines (European Patent EP0919246, 2002), for which he led the development and validation, including filing with US FDA. Guido is the author of the FDA preferred method for validation of package sterilization in aseptic packaging machines (Food Control 11(1):57-66 · February 2000). In recent years, he has focused on field aseptic performance (quality of aseptic production and risk of commercial sterility failure), he has been involved in several troubleshooting cases and, as a technical consultant, on litigations and lawsuits. Guido has developed a software tool to optimize the collection of aseptic quality data and analyse aseptic performance, for which a patent is pending (WO2016/055470). Guido is an active member of the Institute for Food Thermal Processing Specialists, which granted him in 2016  the Marvin Tung Award in 2016 “for outstanding achievement in the preservation and packaging of foods”.

  • Anne Barker-Smith

    Anne received her Master of Science degree in Agriculture & Life Sciences /Food Safety & Regulatory and her BS Food Science & Technology /Business & Marketing from Virginia Tech (VA, USA). Professional with 30 years’ experience in the food industry,  she is a recognized consultant in Preventive Controls for Human Foods, GMP’s, SSOP’s, HACCP, COOL, NLEA, Labeling, Adulteration and Misbranding Laws.  She was a member of Deloitte/IFT/FDA FSMA Guidance Documents Preparation Committee and president of the Virginia Food and Beverage Association. Anne specializes in compliance with GFSI (SQF), FSMA and all other Food Safety and Food Security programs currently required by the USDA, FDA, and the Bioterrorism Act of 2002. She is President/Owner of A. Barker -Smith Consulting, LLC, Beaverdam, VA, USA

 
 
 
 

Contact us

9140 Temse

Belgium

Tel :  +32 495 12 49 95

info@klaratech.com

www.klaratech.com

BTW BE0843.751.728

Klaratech

Your Thermal Process Authority In Europe