Validation Protocol of Vaccine Vials for Quality Storage Temperature under Laboratory Conditions


  • Amit Kumar



Validation, Deep freezer, Quality storage, Vaccine, laboratory conditions, Quality attributes.


Quality of liquid vaccine product in vaccine glass vials is a critical issue and an also important to deliver it with
safe and potent conditions to the recipient for preventing disease burden in public. In case of multi-dose vaccine
vials, safety and potency delivery to the recipient is more critical as compare to single dose vaccine vial. Vaccine
vial of liquid multi-dose oral polio vaccine is under taken for validation study during its storage conditions.
Therefore, current study was designed and performed with objective for validating to prevent breakage of liquid
bivalent oral polio vaccine (LbOPV) vials with acceptance criteria of their quality attributed during the period
of two years from manufacturing to expiry date of the vaccine for quality storage at -200C ±20C temperature
in deep freezer under laboratory conditions.

Author Biography

  • Amit Kumar

    Deputy General Manager (Quality Assurance and Training), Quality Assurance and Training Department,
    Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), Oral Vaccine Plant, Chola, Bulandshahr, Pin Code ‑ 203203, Uttar Pradesh, India