Propharmabi's works in the Fine Chemicals industry

Fine chemicals (APIs)

Fine chemicals (APIs)

The fine chemicals sector faces challenges on multiple fronts: regulatory compliance following the standards and regulations of the various industrial sectors that use the active ingredients produced; continuous technological innovation that allows for top-quality excellence. While compliance is a necessary condition, what makes the difference is cross-sector experience, continuous updating, and attention to operator safety. Propharmabi is the ideal partner for the Fine Chemicals sector because it excels in all these areas. 
The chemical industry is the foundation of many essential products for our society, both in terms of technological innovation and everyday life: pharmaceuticals, fertilizers, nanotechnologies, detergents, electronic components... all rely on chemical components. 
The chemical industry is divided into three main categories based on the product: basic chemicals (which produce commodity chemicals), fine chemicals, and specialty chemicals. Basic chemicals are used to produce fine chemicals, which in turn are combined to obtain specialty chemicals. 
Fine chemicals are pure substances produced in limited quantities in multipurpose facilities through multi-step chemical or biotechnological processes (batch processes), and are more expensive than commodities. Fine chemicals include the active pharmaceutical ingredients (APIs) used in the pharmaceutical industry, as well as peptides, proteins, enzymes, steroids, alkaloids, biocides, and other substances that serve as the basis for patented products in sectors such as agrochemicals, electronics, and photography. Fine chemicals is a particularly challenging industrial sector: strict regulations combined with the fast pace of technological innovation in production processes require constant updating. 
 
The requirements for fine chemical products are closely linked to the standards of the end-use industry (for example, pharmaceuticals in the case of APIs). Quality control processes must ensure compliance with parameters such as molecular structure, composition, concentration, purity and stability, efficiency, yield, and productivity at every stage of processing. 
 
The regulatory requirements are strict and apply to all phases of processing, from the permits needed to handle potentially hazardous substances to the regulations governing storage, treatment, transportation, disposal, and management of the impact on the environment and human health. It is clear that this is a sector in which the design and construction of departments, laboratories, cleanrooms, and facilities requires specific and expert knowledge—such as that offered by Propharmabi.
Areas of Intervention

Areas of Intervention

  • Reactor loading boxes
  • Centrifuge boxes
  • Drying with double cone dryers
  • Drying with static dryers
  • Drying with filter press
  • Granulation/mixing
  • Micronization
  • Bulk packaging
  • Equipment washing areas
  • Processing boxes for highly corrosive products
  • Extraction systems for chemical synthesis areas
  •  Supervision of production processes
 

Reference Standards 

 
In the context of Fine Chemicals and Active Pharmaceutical Ingredient (API) manufacturing, a key aspect is ensuring compliance with Good Manufacturing Practices (GMP). 
GMP comprises a comprehensive framework of rules, standards, and guidelines that define the correct procedures for the production of high-purity chemical substances used as APIs, as well as intermediates and excipients. 
 Good Manufacturing Practices (GMP) 
ICH Guidelines (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Specifically, the standards applicable to controlled environments and cleanroom operations in the Fine Chemicals and API sector include: 
  •  European Pharmacopoeia (Ph. Eur.) – for quality specifications of APIs and excipients 
  •  ISO Standards: ISO 14644 – Cleanroom and associated controlled environments ,  ISO 13485 – Quality management systems for medical devices (when relevant) ,  ISO 14698 – Biocontamination control 
  •  ATEX Directives: Directive 2014/34/EU – Equipment and protective systems intended for use in potentially explosive atmospheres;  Directive 99/92/EC – Minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres.
This regulatory framework ensures product quality, safety, and environmental control throughout the API production lifecycle.

Our work in the Fine Chemicals industry

Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry
Propharmabi's works in the Fine Chemicals industry