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:
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- The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill.
2.0 Scope:
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- This procedure is applicable for the cleaning and operation of Colloid Mill used at the drug formulation plant.
3.0 References & Annexures:
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References:
- Equipment manual
- SOP for Area & Equipment Usage Log
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4.0 Responsibilities:
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- Production Operator:
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- To perform the cleaning and operation of Colloid Mill as per SOP.
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- Production Officer:
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- To check proper cleaning and operation of Colloid Mill as per SOP.
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- To maintain the Area & Equipment Usage Log.
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- User Department Head or Designee:
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- To ensure the cleaning and operation of Colloid Mill as per SOP
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- Quality Assurance:
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- To ensure the cleaning and operation of Colloid Mill as per SOP
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- Regulatory Affairs, Quality Head and Plant Head:
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- To review and approve the SOP.
5.0 Distribution:
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- Production
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- Quality Assurance
6.0 Abbreviations:
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- BMR: Batch Manufacturing Record
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- MRO: Material Requisition Order
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- QA: Quality Assurance
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- SOP: Standard Operating Procedure
7.0 Procedure:
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Checks & Precautions:
- Wear acid and alkali proof hand gloves, nose mask (wear protective head gear), cleaning while cleaning.
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- Cover Colloid Mill motor cabinet with polybag during the cleaning of the equipment.
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- During process operators, the helper must wear a nose mask, headgear, secondary gown, and hand gloves.
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Cleaning procedure for product to product change over:
- Ensure that ‘To be Cleaned’ label is put on the equipment.
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- 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.
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- Discharge the potable water from hopper.
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- 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)
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- Pour 1 liter of 2% Non-ionic solution & run the equipment for 5 min & then discharge.
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- Pour 5 liter of potable water into the hopper & then press the start button to run the Colloidmill for 5 min& then discharge.
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- Take 5 liters purified water into the mill and circulate for 5 minutes and then discard.
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- Switch ‘OFF’ (Pressing of Red color button) electrical supply and wipe out with dry clean cloth.
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- Note: The cleaning of the equipment remains valid for 48 hours.
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- If the equipment is not used within 48 hours, then it should Re cleaned as per product changeover before use.
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Cleaning Procedure for the batch to batch changeover:
- Ensure that ‘To be Cleaned’ label is put on the equipment.
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- Switch ‘OFF’ the mains.
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- Wipe the external body with a dry clean duster.
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- Check for the cleanliness of the colloid mill.
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- Attach partial clean card and take line clearance from QA.
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- Note: The cleaning of the equipment remains valid for 48 hours.
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- If the equipment is not used within 48 hours, then it should Re cleaned as per product changeover before use.
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Operating procedure:
- Affix ‘Under Process’ label on the equipment.
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- Switch ‘ON’ the equipment.
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- Transfer the solvent mentioned qty. for milling in BMR & MRO.
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- Press the start button & mill for the required time mentioned in BMR.
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- Place a cleaned SS tank under the discharge point.
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- After completion of milling discharge, the milled solution in the SS tank placed below the discharge point of the colloid mill.
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- Keep the discharge valve open for the single-pass requirement.
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- Keep the discharge valve closed for multi-pass requirement; adjust the rate of fluid discharge by controlling the discharge valve opening.
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- Switch ‘OFF’ the electric supply.
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- Remove the ‘Under Process’ label.
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- Affix ‘To be Cleaned label’ on the equipment.