Benzyl alcohol (BA) is used in injectable products mainly as an antimicrobial preservative (especially in multi-dose containers) and sometimes as a co-solvent to help dissolve an API. Here’s what matters most when you’re considering it in an injectable formulation. Where…
1. Pre-entry checks (outside change room) Before even touching the change room door: 2. Change Room – Stage 1 (Black to Grey) Purpose: Remove gross contamination from outside environment. 3. Handwashing & Hand Disinfection Performed before putting on sterile gloves.…
Operational Qualification (OQ) for Vibro Sifter [PICTORIAL] Check that the Vibro sifter operates correctly without product under defined operating ranges. Typical OQ tests & checks: Operational Qualification Acceptance:
Typical Installation Qualification for Vibro Sifter [Pictorial] checks: Installation Qualification for Vibro Sifter (Acceptance Criteria):All items verified and found compliant; deviations evaluated and closed.
In pharma, disinfectant efficacy validation is the documented proof that your chosen disinfectants, at their actual in-use dilution and contact time, can control the real microflora on the real surfaces in your facility, as part of your contamination control strategy.…
Fogging in pharma is a whole-room disinfection method where a disinfectant is aerosolized into a fine mist (fog) to cover all exposed surfaces and the air in controlled areas like cleanrooms and sterile production zones. It is an additional step,…
Daily balance verification in pharma is the routine, documented checking of analytical balances each day they’re used to ensure they are accurate and fit for use in GMP testing. It’s a pre-use fitness check, not a full calibration. Here’s a…
1. Basic Concept 2. Comparison Table Aspect Manual Decartoning Decartoning Machine Manpower requirement High – multiple operators needed for big batches Low – 1–2 operators to load, monitor, and unload Speed / Throughput Moderate, depends on operator skill & fatigue…
PERSONNEL ASEPTIC QUALIFICATION COMPILED REPORT BY RODAC (CONTACT PLATE) METHOD 1.0 REPORT DETAILS 2.0 OBJECTIVE The objective of this report is to summarize the execution and results of aseptic personnel qualification in pharma performed using the RODAC (contact) plate method,…
1. Objective 2. Pre-Start Checks Before touching START: 3. Setting up the Machine 4. Trial Run & Optimisation 5. Routine Operation of Compression Machine 6. Safety & GMP Behaviour 7. Completion of Batch