Integral Services in Process Authority for validation of thermal treatments in autoclaves, cookers and continuous pasteurizers.

ALSERCO offers high-performance measurement devices and a team of specialists with specific training through global organizations endorsed by FDA such as IFTPS, in matters of Better Process Control School (BPCS), Analysis of Thermal Treatments, Design and Interpretation of Heat Distribution and Penetration Studies.

Our team of specialists count with a extensive experience working with documentation and  FDA products registration: thermo processed and hermetically packaged, low acid products (LACF) and acidified foods (AF). Likewise, with extensive curriculum in the field of R&D, publications and patents. Various international projects or collaborations for autoclaves design with efficient temperature homogenization, design of accessories and validation methods process, analysis of critical control points and including participation and research on autoclave control procedures and systems based on the control of cold areas through algorithms based on neural networks.

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ALSERCO is currently developing cooperation activities with the Spanish Health Authorities (SERGAS), training the sanitary inspectors for the technical evaluation of autoclaves, cookers and the interpretation of thermal processes validation studies.

Recognition as a Process Authority and FDA policy by companies operating in this field.

The US through US Food and Drug Administration (FDA) does not recognize in any list any company that acts as a Process Authority. However, FDA is aware of the technicians who perform validations and registrations at FDA, as well as their curriculum and career. The ALSERCO Process validation team has extensive experience in this area.

Temperature distribution studies

Development of temperature distribution studies for validation and configuration of efficient heating times, control of temperature homogenization parameters in the autoclave and temperature analysis mapping, cold areas of the machine and / or lower lethality .

Heat penetration studies

For the heat treatment development in foods of low acidity or acidified, hermetically sealed and preserved by heat. Fo Studies to obtaining sterilization times, in established processes and new product developments. Analysis of critical process control points.

Validation studies in tuna, sardine and mollusc cookers. Test 90-90

Cookers working characteristics analysis to verify the temperature homogenization and heat penetration.

The 90-90 test is a requirement to be analysed according the European norm 853/2004 where described all the specified about animal origin food and established the hygiene conditions in a food safety conditions.

Development of back pressure for flexible packaging

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To obtain the necessary pressure curve in the autoclave, having a deformation-free and safe heat treatment. This studies are carried out with a high performance measuring device and  a high technical protocol that is necessary to ensure adequate results.

The right treatments established, prevent food safety failures during the thermal cycle by keeping the appropriate parameters values. At any process deviation the margin of safety is also achieved maintain in the strength of the container with the right parameters.  But if the back pressure cycles are poorly established can cause deformation due to the minimum deviation or incidence, causing production losses.

Z-Soft® - Continuous monitoring software. Security and Control of Process Deviations.

It is a management software, with a Validation and Deviation Control module allows to link the thermal cycles in execution with the parameters and critical points established by the Process Authority for each product. Continuous monitoring system prevents human failures such as incorrect recipes or production processes located out of ranges determined in the validation.

It keeps historic results studies to accurately provide only useful information to operators and Quality personnel in case of failure or deviation. The purpose of this application is to facilitate  actions of operators in case of process failures, increase food safety and avoid unnecessary production losses.

FDA electronic record management

Products and processes for canning companies that want to export their products to the US.

ALSERCO with its validation service and Process Authority includes for those clients that require it the management of the FDA electronic registration. There is also a consulting service to help with the adaptation of processes and requirements in those companies that want to start their exports to the US or need to accompany their FDA audits and inspections.