Abhimanyu_Awasthi_ Vaccines Storage & Stablity 08-07-2021.pptx

Vaccine Storage & Stablity.

1. Rungta College of Pharmaceutical Sciences & Research. Topic- Storage conditions & stability conditions of Official Vaccines. Presented By- Abhimanyu Awasthi. 307204119301

2. List of various available Vaccines. Available vaccines Cholera - O ral cholera vaccines (OCV): Dukoral ®, Shanchol ™, and Euvichol ®. Dengue- Dengvaxia (CYD-TDV) . Diphtheria- DTwP/DTaP . Hepatitis- Hb V Haemophilus influenzae  type b (Hib): HiB Conj -V Human papillomavirus (HPV): HPV recombinant vac. Influenza - Flu Shot. Japanese encephalitis- JEV(IXIARO) Malaria- Mosquirix Measles- MMR Meningococcal meningitis- MCV Mumps- MMR Pertussis- DPT Pneumococcal disease- PCV Poliomyelitis- Inactivated PV Rabies- Human Diploid Culture V Rotavirus- RotaTeq Rubella-MMR Tetanus- DPT Tick-borne encephalitis- TBEV Tuberculosis- BCG Typhoid- Vivotif (Ty-pills) Varicella- VV Yellow Fever- YF-VAX

3. Coronavirus/ COVID-19 Vaccines RNA vaccines  Pfizer–BioNTech- Corminaty  Moderna – mRNA 1273, Spikevax Protein sub vaccines EpiVacCorona-Peptide Based Vaccine ZF2001-ZIFIVAX Inactivated virus vaccines   Sinopharm (BBIBP)-BBIBP-CorV   CoronaVac - Sinovac    Covaxin - BharatBioTech , ICMR   Sinopharm (WIBP)-WIBP- CorV    CoviVac - CHUMAKOV    QazCovid -in- QazVac Adenovirus vector vaccines   Oxford–AstraZeneca – Covidsheild / Vaxzevira     single dose Sputnik V- Gamaleya   Johnson & Johnson- Jansen covid-19 vaccine.     single dose Convidecia - AD5-nCOV     single dose Sputnik Light- AD26 Vector.

4. List of Vaccines under Pipeline Development. Pipeline vaccines Campylobacter jejuni Chagas Disease Chikungunya Enterotoxigenic Escherichia coli Enterovirus 71 (EV71) Group B Streptococcus (GBS) Herpes Simplex Virus HIV-1 Human Hookworm Disease Leishmaniasis Disease Malaria Neisseria gonorrhoeae Nipah Virus Nontyphoidal Salmonella Disease Norovirus Paratyphoid fever Respiratory Syncytial Virus (RSV) Schistosomiasis Disease Shigella Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyrogenes Tuberculosis Universal Influenza Vaccine

5. Storage Conditions for different Vaccines. Stand- alone units are recommended; self-contained units that only refrigerate or freeze, and are suitable for vaccine storage.35° F and 46° F ( -2° C and 8 ° C) While CDC does not recommend specific brands of vaccine storage units, CDC does provide guidance on types of storage units that offer greater assurance of proper temperatures for vaccine storage based on equipment testing by the National Institute of Standards and Technology (NIST). CDC recommends stand-alone units, meaning self-contained units that only refrigerate or freeze, and are suitable for vaccine storage. These units can vary in size, from compact, under-the-counter style to large, stand-alone, pharmaceutical grade units. Have enough room to store water bottles (in the refrigerator) and frozen coolant packs (in the freezer) to stabilize the temperatures and minimize temperature excursions that can impact vaccine potency. The addition of water bottles in the refrigerator (not coolant packs) reduces the risk of freezing due to the tremendous latent heat released from water prior to freezing;Have a calibrated thermometer inside each storage unit. Reliably maintain the appropriate vaccine storage temperatures year-round;Be dedicated to the storage of vaccines. Food and beverages should NOT be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.-50° F and – 15° F ( -58° C and + 5 ° C).

6. Refrigerator and Freezer Vaccine Storage Guidelines Storing: Place vaccines in breathable plastic mesh baskets. Label each basket with vaccine type. Keep labeling methods consistent across all baskets. Store empty shelves and doors with full water bottles (refrigerator) or frozen packs (freezer) and label as ‘DO NOT USE’. Place a recommended temperature monitoring device in the unit. Place a warning sign on the storage unit that says, ‘Do not adjust refrigerator or freezer temperature controls.’ Store vaccines with similar packaging and names (e.g., HB and Hib or Tdap and Td) in dierent locations of the unit. Keep vaccines in their original packaging to protect against exposure to light. Always store foods in a separate unit. Frozen vaccines must be stored in a frost-free freezer. Do not use bar-style fridges or freezers and/or cyclic defrost freezers, as they can result in significant temperature variations in the unit. Maintenance: Review expiration dates regularly and rotate vaccines with closer expiration to the front to be used first. Remove expired vaccines from the unit and label them as expired. Monitor vaccine storage to prevent shortage and over-ordering during low- and high-season demands.

7. Stability of vaccines. Stability is the ability of a vaccine to retain its chemical, physical, microbiological and biological properties within specified limits throughout its shelf-life. Factor affecting stability of vaccines. Purity Formulation Stabilizers eg - Human Serum Albumin (HAS), recombinant human Albumin ( rHA ), Gelatine, Sugars, Sorbitol Thiomersal AlOH , AlPO Ions (Buffer systems) . Pharmaceutical form Lyophylized versus liquid . Storage Frozen versus refrigerator.

8. Types of Stability Testing. Real Time Stability-Real Time Stability: Long term: Long term stability under recommended storage stability under recommended storage conditions for the shelf life proposed for the product. Accelerated Testing Studies under exaggerated storage conditions. Stress studies- More severe conditions than those used for conditions than those used for accelerated studies.

9. THANKYOU.