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    Category: Contamination Control

    FDA 483 #10 – Non-Viable Particle Counting

    Learning Objectives Discuss the importance of particulate in relation to microorganisms Explain why 0.5 micron and larger sized particles are of great importance Discuss 3…

    Seth DePasquale, R.Ph., BCSCP November 6, 2020
    0 Comments

    FDA 483 #9 – Bacterial Endotoxin Testing

    Learning Objectives Discuss the importance of low levels of endotoxins in parenteral preparations Discuss the limits for endotoxins for various routes of administration Discuss ways…

    Seth DePasquale, R.Ph., BCSCP October 16, 2020
    0 Comments

    Can we share Stability Studies?

    I received this question this week: What do you think about sharing a stability study with another pharmacy? Would that be acceptable? I tried to…

    Seth DePasquale, R.Ph., BCSCP October 12, 2020
    0 Comments

    483 Friday #7 – Viable Air Sampling

    Learning Objectives Explain the purpose of viable air sampling Discuss how conclusions can be made from the results of viable air sampling Happy Friday! This…

    Seth DePasquale, R.Ph., BCSCP October 2, 2020
    0 Comments

    483 #6 – Cross-Contamination

    The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be…

    Seth DePasquale, R.Ph., BCSCP September 25, 2020
    0 Comments

    FDA to USP: Sterility is top concern with extended BUDs

    Tomorrow, September 15, 2020, the USP will be having a call for comments regarding the appeals related to extending Beyond Use Dates in USP Chapter…

    Seth DePasquale, R.Ph., BCSCP September 14, 2020
    0 Comments

    483 #4 – Investigations & CAPAs

    Learning Objectives Explain how action levels are used to maintain a controlled environment Define the 5 steps to DMAIC Explain the 5 why’s technique for…

    Seth DePasquale, R.Ph., BCSCP September 8, 2020
    0 Comments

    What the…what’s Water Activity (Aw)?

    There’s been a “new” term that’s been introduced with the revision of USP <795>, Water Activity. There’s an entire 2 page USP Chapter about water…

    Seth DePasquale, R.Ph., BCSCP September 7, 2020
    0 Comments

    483 #3 – Smoke Studies and Media Fills

    Learning Objectives Explain the purpose of smoke studies Define the two types of smoke studies that need to be performed Explain the two conditions under…

    Seth DePasquale, R.Ph., BCSCP September 3, 2020
    2 Comments

    483 #2 – Facilities & Equipment

    Learning Objectives Explain the conditions USP Chapter <797> states for surfaces in classified areas Discuss what USP Chapter <797> says about gaps in ceiling tiles…

    Seth DePasquale, R.Ph., BCSCP August 21, 2020
    0 Comments
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    Recent Posts

    • FDA 483 #10 – Non-Viable Particle Counting
    • FDA 483 #9 – Bacterial Endotoxin Testing
    • Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?
    • Can we share Stability Studies?
    • FDA 483 #8 – Using ungraded ingredients

    Recent Comments

    • Bret Snow on You received a 483? Don’t Panic…
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
    • Seth DePasquale, R.Ph., BCSCP on Cleaning up Confusion; correctly cleaning your room
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust
    • Seth on 483 #3 – Smoke Studies and Media Fills
    © 2025 - Sterile.AF
    483 #2 - Facilities & Equipment

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