Skip to main content

Dry heat sterilization


PDA Technical report No. : 3 (Revised 2013)
Dry heat process used for sterilization and depyrogenation.
Bacterial Endotoxin Test (BET) - Assay for measuring active endotoxins by combining a liquid test sample with LAL (Limulus Amoebocyte Lysate) reagent and measuring the resulting proportional reaction via visual, turbidimetric, chromogenic, or other validated means of detection.
BI Challenge system - A test system containing viable microorganisms of pure and specified strain providing a defined resistance to a specified sterilization process.
Depyrogenation - Destruction and /or removal of bacterial endotoxins. It demonstrates at least 99.9 % or 3 Log endotoxins reduction.
D- Value- Time in minutes required for a one-logarithm or 90% reduction of microorganisms used as biological indicator under specified lethal conditions.
Dwell Time- Period that items are subjected to a given processing conditions.
Endotoxin Indicator (EI) for depyrogenation - Vial of endotoxin (or a carrier spiked with endotoxin) designed for use in depyrogenation studies. Endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP endotoxin units/ carrier. The endotoxin indicator would allow for accurate indication of at least a 3 Log reduction in USP endotoxin units during depyrogenation process challenges.


Tunnel Biological indicator ======Fix the thermocouples along with Biological indicator (Bacillus Atrophaeus) on the cooling chamber internal surface/belt by opening

Labels:

Comments

Post a Comment

Popular posts from this blog

AMFSS (Aseptic Media Fill Simulation Study)

Guidelines - 1. PDA Technical report No.: 22- "Process Simulation Testing for Aseptically Filled Products". 2. PDA Technical report No.: 44- "Quality Risk Management for Aseptic Processes". 2. PIC'S (Pharmaceutical inspection convention or Pharmaceutical inspection co-operation scheme) 3. USFDA Guidance to industry (Sep/2004)- "Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, September 2004" 4. European guideline to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products, (corrected version) November 2008. Aseptic Media fill Simulation Study necessary to- *Qualify the process line *Qualify the personal *Qualify the container- closure system Media fills may be used to: 1. Support new or revised aseptic processes are operating under the desired state of control. 2. Periodically confirm the aseptic pr...
Post a Comment
Read more

NVPC

NVPC Online NVPC: Make= Beckman; Model= Met one 6015P; Capacity= 1CFM SOFTWARE= EnVigil Critical alarm: Critical alarms are those alarms when generated indicate excursion which may impact the product quality. Alarm generated in location where the NVPC probe is in close proximity to the product/ sterile container closure/ product contact path. Location for critical alarms includes grade A location - Filling station, Bunging station, Bunging Hopper station, Portable cart, IOS station, AGV station, Near lyophilizer door open, between lyophilizers (near Lyo) and Lyo LAF (rigid barrier transfer conveyor). Critical alarms include the following- 1.     Particle count excursion beyond the acceptance criteria at a particular location. 2.     Sensor Failure, Counter Flow Failure, ERROR or SKIPPED message. Ensure and verify the status of counter flow to meet the below set limit- Target Counter flow – 1.0 CFM. Minimum counter flow: ...
Post a Comment
Read more

Audit and compliance

Audit readiness Reference https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf https://ispe.org/initiatives/regulatory-resources/gmp/audit-checklist# Before start of audit we need to review past audits and note indication of possible problem areas and items, if any ensure that were identified for corrective actions in a previous audit. If not aware about facility learn what products being produced and how it is organised with personal and function. To have systematic audit checklist to be prepared and alongwith notebook it needs to be utilised (notebook required to make detailed entries while audit and checklist is to guide auditor). Atleast three production batches to be selected For thorough analysis to include- a) Traceability of all components or materials used in that batch. b) Documentations of raw materials or components, inprocess and finished goods testing for subject product batches. c) Warehousing and distribution reco...
Post a Comment
Read more