SOP for Operation and Cleaning of Colloid Mill

Standard Operating Procedure for operation and cleaning of the colloid mill. contains Checks & Precautions, Cleaning procedure for product to product changeover, batch to batch changeover, etc.

SOP for Operation and Cleaning of Colloid Mill

1.0       Purpose:

    • The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill.

2.0      Scope:

    • This procedure is applicable for the cleaning and operation of Colloid Mill used at the drug formulation plant.

3.0      References & Annexures:

    • References:

    • Equipment manual
    • SOP for Area & Equipment Usage Log

4.0      Responsibilities:

    • Production Operator:
    • To perform the cleaning and operation of Colloid Mill as per SOP.
    • Production Officer:
    • To check proper cleaning and operation of Colloid Mill as per SOP.
    • To maintain the Area & Equipment Usage Log.
    • User Department Head or Designee:
    • To ensure the cleaning and operation of Colloid Mill as per SOP
    • Quality Assurance:
    • To ensure the cleaning and operation of Colloid Mill as per SOP
    • Regulatory Affairs, Quality Head and Plant Head:
    • To review and approve the SOP.

5.0      Distribution:

    • Production
    • Quality Assurance

6.0      Abbreviations:Colliod-Mill-Equipment

    • BMR: Batch Manufacturing Record
    • MRO: Material Requisition Order
    • QA: Quality Assurance
    • SOP: Standard Operating Procedure

7.0       Procedure:

    • Checks & Precautions:

    • Wear acid and alkali proof hand gloves, nose mask (wear protective head gear), cleaning while cleaning.
    • Cover Colloid Mill motor cabinet with polybag during the cleaning of the equipment.
    • During process operators, the helper must wear a nose mask, headgear, secondary gown, and hand gloves.
    • Cleaning procedure for product to product change over:

    • Ensure that ‘To be Cleaned’ label is put on the equipment.
    • Pour 5 liter of potable water into the hopper & then press the start button (Green color button) to run the Colloid mill for 5 min.
    • Discharge the potable water from hopper.
    • Scrub the previous batch adhered material on colloid Mill using a 2% non-ionic solution with the help of nylon scrubber.

Also visit : Hold Time Study of Cleaned Equipment (CEHT)

    • Pour 1 liter of 2% Non-ionic solution & run the equipment for 5 min & then discharge.
    • Pour 5 liter of potable water into the hopper & then press the start button to run the Colloidmill for 5 min& then discharge.
    • Take 5 liters purified water into the mill and circulate for 5 minutes and then discard.
    • Switch ‘OFF’ (Pressing of Red color button) electrical supply and wipe out with dry clean cloth.
    • Note: The cleaning of the equipment remains valid for 48 hours.
    • If the equipment is not used within 48 hours, then it should Re cleaned as per product changeover before use.
    • Cleaning Procedure for the batch to batch changeover:

    • Ensure that ‘To be Cleaned’ label is put on the equipment.
    • Switch ‘OFF’ the mains.
    • Wipe the external body with a dry clean duster.
    • Check for the cleanliness of the colloid mill.
    • Attach partial clean card and take line clearance from QA.
    • Note: The cleaning of the equipment remains valid for 48 hours.
    • If the equipment is not used within 48 hours, then it should Re cleaned as per product changeover before use.
    • Operating procedure:

    • Affix ‘Under Process’ label on the equipment.
    • Switch ‘ON’ the equipment.
    • Transfer the solvent mentioned qty. for milling in BMR & MRO.
    • Press the start button & mill for the required time mentioned in BMR.
    • Place a cleaned SS tank under the discharge point.
    • After completion of milling discharge, the milled solution in the SS tank placed below the discharge point of the colloid mill.
    • Keep the discharge valve open for the single-pass requirement.
    • Keep the discharge valve closed for multi-pass requirement; adjust the rate of fluid discharge by controlling the discharge valve opening.
    • Switch ‘OFF’ the electric supply.
    • Remove the ‘Under Process’ label.
    • Affix ‘To be Cleaned label’ on the equipment.

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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