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

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

& regulation

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

  • Unit Operations and Validation in aseptic packaging  

  • Failure modes and effects of failures in aseptic packaging

  • 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

 

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