GMP in pharmaceutical industry

07/03/2018

Pharmaceutical industries produce all kind of medicines in many different dosages and shapes, such as pressed or compressed powders, capsules, liquid solutions. Each product must be made on a different production line, by respecting the very strict Good Manufacturing Practices (GMP).
 

I- GMP is important


GMPs are the practices defined by global regulatory agencies to guarantee product’s quality standards. Manufacturing process must ensure product’s safety, purity and efficiency.
Respecting the GMP is necessary to:
  • manage a reliable and secure supply chain
  • avoid cross contamination between different chemical components and other contaminations
  • keep the manufacturing operations efficient
  • provide high quality products


The entire production process must be compliant with GMP regulations, from the production of materials, the workenvironment and the equipment to the training and personal hygiene of the authorized personnel. Each step of the production must be well-documented to prove the full respect of procedures at each step of the manufacturing process.

Moreover, following GMP regulation is necessary for the commercialization of medicines on the market.
 

II- The cross contamination in pharmaceutical industry


Cross contamination is one of the major threats of production lines.
Somehow, every step of the process may contaminate the product: dispensing, blending, dosage shaping, compression, filling, coating, polishing and packaging.

There are three kinds of cross contamination:
  • physical contamination: particles, powder from the compression machine
  • chemical contamination: steam, moisture, molecules
  • biological contamination: bacteria, fungus, virus
 

1. How to avoid cross contamination?

  • by constantly cleaning the work environment (floor, machinery, tools, furniture…)
  • by keeping top hygiene levels and reducing risks
  • by sucking and removing at the source, on strategic points of the manufacturing process: picture
  • by not letting any chance to the material to slide or to fall on the production process.
The suction solution is fast, clean and easy to set up on the supply chain.

2. Delfin solutions to cross contamination in pharmaceutical industry

Delfin manufactures industrial vacuum cleaners suitable for any kind of pharmaceutical powder like the MTL 3533(compact & mobile). Each vacuum is available in ATEX version and with HEPA filtration for use in potentially explosive atmospheres.
Delfin’s solution for general cleaning in pharmaceutical environments: the Pharma 3533 XXX.

 

III- Special case: the clean rooms

Most of the time, pharmaceutical supply chains are settled in clean rooms In these rooms, the number of particles per cubic meter at a specified particle size are always kept under control. The main characteristic is the ulta-low concentration of dust micro-particles suspended in the air.
Each equipment used or in function in this area must not interfere with the level of particles suspended in the air. Any equipment must respect ISO classification, the global reference, dividing the cleanrooms in different classes, according to their contamination level and to the activity.
Delfin engineered a specific range of special industrial vacuum cleaners to both respect ISO classification and keep efficient cleaning with the LabControl range.

Contact us at +0039 011 800 55 00 or send us an email to delfin@delfinvacuums.it to find out the best suction solution to your needs!

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