Glass-lined reactors for active pharmaceutical ingredient manufacturing

Diagram of glass lined reactor

Glass lined reactor model

In Pharmaceutical industries, we come across processes handling acids and sticky materials in batch reactors. Most bulk drugs are manufactured in batch wise operations. Acid reactions and crystallisation operations were performed in stage wise repeatedly from initials raw materials treatment to final purification of product. Active pharmaceutical ingredient abbreviated as API is the key compound of the drug designed to perform treatment to the health problems. Regulatory bodies like FDA (Food and Drug Administration) strictly advices and inspects the cleaning of the reactors that are used for processing API. Drugs like Nizatidine, Sertraline HCl and Fluconazole stick to the surface of stainless steel reactor even after thorough cleaning with water and methanol their trace are found by conducting the swab test. The glass-lined reactor solves this problem of contamination.

 

Equipment Description of Batch Type Glass-lined Reactor:

 

Basic reactor model contains the blue coloured glass lining inside its surface. Dome is fitted to the cylindrical vessel by “C” type clamps placing food grade gasket between them and the vessel has an opening at the bottom. The hemispherical dome has provision to fit thermocouple, agitator, dip rod and baffles. Dome and every part exposed to the API are glass lined. Heat transfer to the reactants in the reactor is provide by circulating the heating media like steam through the circular tubes fitted outside the vessel mostly half pipe jacket was used. PTFE lined accessories are used to prevent the stress during the assemble on the nozzles for dip tubes and spargers. Sleeve with PTFE lined are used for mounting the accessories on the doom.

Types of external baffles used to improve the flow pattern:

  • Fin baffle
  • d-type baffle
  • h-type
  • Finger baffle
  • Beaver-tail baffle

For performing distillation and cleaning operations, these glass-lined reactors also have provision for reflux line, vapour line, nitrogen purge line, and vent line. Some of the mertis and demerits of glass-lined reactor are:

Merits

Demerits

  • Easy and effective cleaning operation between batches
  • Suits for batch distillation
  • Withstands to acidic and ionic solutions
  • Prevent scale formation
  • Glass fragile nature
  • Difficulty to repair the breakage section
  • Low operating pressure