28

2021

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09

QC for GMP mixer in food and pharmaceutical industry


Food safety has always been an issue of great concern to our society. Except for those we eat directly on the table, many things that closely related to our daily food need to be taken more seriously by manufacturers, relevant authorities and equipment suppliers. What we see every day, e.g. flavoring, spice, three-in-one coffee, nutritional milk powder and many APIs, they are processed through different equipment Mixing process is one of the most important steps in the whole cycle, while GMP or food grade mixing equipment is a minimum requirements when you get involved in this kind industry. This usually can be verified through inspections during processing and production, QC before delivery, on-site installation and commissioning.

 

PMI for metallic materials

Because the equipment is made of stainless steel 316L, we have carried out PMI testing on all incoming materials to ensure the reliability and traceability.

 

 

Non-metallic materials certificate

Requirements of food & pharmaceutical industry are higher than those of the chemical industry. Equipment suppliers should provide corresponding supporting documents of GMP certificates for customers.

 

 

RT and PT

In order to prevent deformation or dead corners and guarantee the polishing quality after welding, process qualification were carried out on welding height and welding requirements, as well as RT ray inspection and PT color penetration inspection on the welds. Make sure welding is qualified before next step of installation. 

 

 

Polishing

In addition, we also tested the surface finish after polishing. For GMP requirements, it requires Ra<0.8 for the mixer part contact with material, some even require higher standard like Ra 0.4. Finally we did the inspection by roughness measuring instrument on all parts contacted with the material, including mixer body, main shaft, agitator, endplates, etc.

 

 

Pollution prevention

As the equipment for food industry is made of fully stainless steel, in order to avoid carbon steel pollution, we have specially arranged an independent workshop for sheet metal and assembly work. In addition, wooden plates were placed at the bottom of the equipment to avoid scratches or during installation, hoisting and unloading.


 

CIP cleaning

Now in food and pharmaceutical industry, vertical ribbon mixer gets popular. It is common that many customers will use one mixer to complete various formulations especially for food industry. This requires higher standard for the material residue and cleaning effect. Normally our vertical ribbon mixer GPH Series can achieve fully discharging without residues. Besides, a side cleaning door is designed on the mixer body for manual cleaning.

 

 

Riboflavin test

However, the most important step is checking dead corners inside the equipment. As CIP or WIP cleaning are required for food and pharmaceutical industry. Therefore equipment is tested by riboflavin. First spray the diluted riboflavin solvent evenly on every corner of cleaned mixer’s internal surface, wait for about 2 hours until the reagent adhere to the surface of the equipment, and finally start CIP cleaning nozzles for cleaning. After cleaning, use a professional UV light to check each corner carefully. The position has yellow spots means it can't be covered by CIP cleaning nozzles, which are dead corners. Only if there is no yellow spot, it can prove the internal surface are fully covered by CIP nozzles and cleaned thoroughly.

 

 

Factory Acceptance Test (FAT)

FAT inspection is essential for GMP requirements. We have many items to verify including operation status, noise level, and temperature rise of motor, gearbox and bearing.

 

 

Site Acceptance Test (SAT)

If the production process needs to be certified to get the GMP certificate, on site SAT verification report is essential. The content of the verification mainly involves the equipment installation accuracy, on site operation status, testing with material are qualified, etc.

 

 

Contact our enginneer

Since 1989, S&L is committed to insist food and pharmaceutical safety and providing high standard mixing equipment in line with GMP. Contact us info@mixertec.com to get proposal dedicated for your applications.

 

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