Cleaning validation for blister packaging machines in hospital-supplying pharmacies

Area of Science:

• Pharmaceutical Technology
• Analytical Chemistry
• Quality Assurance

Background:

• Unit-dose blistering is increasingly adopted in hospital pharmacies globally.
• Ensuring quality-assured patient care necessitates validated cleaning processes for blister machines.
• High-performance liquid chromatography (HPLC) is effective but costly for cleaning validation.

Purpose of the Study:

• To develop a novel, rapid, and cost-effective analytical method for blister machine cleaning validation.
• To establish UV-Vis spectroscopy as a viable alternative to HPLC for this purpose.

Main Methods:

• Marker substances (metamizole and paracetamol) were packaged into blisters.
• Blister machines were cleaned, and test tablets were packaged before and after cleaning.
• Contamination was assessed using UV-Vis spectroscopy.

Main Results:

• UV-Vis spectroscopy demonstrated superiority over HPLC for cleaning validation.
• The method is significantly faster and more economical than HPLC.
• It requires less equipment and personnel effort while maintaining reliability and sensitivity.

Conclusions:

• UV-Vis spectroscopy is the first innovative method suitable for cleaning validation of blister machines.
• Cleaning validation of these machines is a mandatory duty of care.
• This method supports the growing use of unit-dose blistering in healthcare.