OPERATION OF VIBRO SIFTER (PICTORIAL)

1.0 OBJECTIVE

To lay down the procedure for safe and GMP-compliant operation of the Vibro Sifter used for sifting of raw materials, granules and blends in the pharmaceutical manufacturing area.

2.0 SCOPE

This SOP is applicable to all vibro sifters installed in production / granulation / dispensing areas of the oral solid dosage facility.

3.0 RESPONSIBILITY

• Operator / Production
  • To operate the vibro sifter as per this SOP.
  • To record all operational details in BMR / logbook.
• Production Officer / Executive
  • To ensure line clearance and correct sieve assembly.
  • To verify entries and in-process checks.
• Engineering
  • To ensure availability of power, earthing, preventive maintenance.
  • To attend any breakdowns and record in equipment history.
• QA / IPQA
  • To verify line clearance and sieve integrity checks as applicable.

4.0 EQUIPMENT DETAILS (EXAMPLE)

• Name of Equipment : Vibro Sifter
• Capacity : 48″ (or as applicable)
• Equipment ID No. : VS-___
• Make / Model : ____________

5.0 SAFETY PRECAUTIONS

• Ensure electrical earthing of the machine is OK.
• Never operate the machine with top cover / clamps open.
• Do not insert hands or tools into the charging port while machine is running.
• Use nose mask, gloves, goggles, ear plugs (if needed) as per PPE matrix.
• Keep area around machine dry and free from powder spillage.

6.0 PRE-OPERATION CHECKS

6.1 Line Clearance

• Ensure previous product material is removed from:
  • Machine, surrounding area, floor, nearby equipment.
• Verify “CLEANED” status label on vibro sifter.
• Confirm correct product name, batch no., batch size, sieve size in BMR.
• Get line clearance from Production and IPQA (if required).

6.2 Sieve Selection & Check

• Select specified sieve (mesh) size as per BMR (e.g. 40#, 60#, 80#).
• Inspect sieve visually for:
  • No tear, no broken wires, no dents, no corrosion.
• Record sieve ID, mesh size, condition in BMR / logbook.
• Fix sieve gasket (if applicable) and ensure no gap between sieve and frame.

6.3 Machine Condition

• Check:
  • All clamps (top cover, sieve frame) are in good condition.
  • Rubber mountings and gaskets/seals intact.
  • Discharge chutes connected properly to containers / bins / FBD bowl.
• Ensure power supply is available and emergency STOP switch works.

7.0 ASSEMBLING OF VIBRO SIFTER

1. Ensure machine is switched OFF and plug is removed / MCB is OFF.
2. Place the required sieve on the sifter deck with proper gasket.
3. Place the retaining ring / frame and fix the top cover with sight glass / vent.
4. Tighten all side clamps uniformly to avoid vibration leakage or powder escape.
5. Position receiving containers / IPC bins at:
   • Fine material outlet (through-sieve).
   • Oversize outlet (retained material).
6. Place poly bags or liners inside containers, if required by SOP.

8.0 OPERATION PROCEDURE

8.1 Starting the Vibro Sifter

1. Ensure material to be sifted is approved and released by QC.
2. Confirm correct labeling on material container (Name, Batch No., Status).
3. Switch ON the main power supply / MCB.
4. Press the START push button:
   • Verify that the machine runs smoothly, without abnormal noise or excessive vibration.
5. Allow the machine to run empty for 30–60 seconds to check vibration and balance.

8.2 Feeding of Material

1. Open the charging port / feed cover.
2. Feed the material gradually using:
   • SS scoop / SS feeding hopper,
   • Or feed directly from bin/FBD through controlled valve.
3. Avoid over-charging; maintain steady feed rate to prevent choking of mesh.
4. If dust extraction is provided, ensure suction ON (if applicable).

8.3 Sifting Operation

1. Continuously monitor:
   • Powder / granule flow from fine outlet.
   • Rejection at oversize outlet.
2. If flow reduces:
   • Gently tap the top cover (if permitted) or stop machine and clean mesh as per SOP.
3. Do not use hard, sharp objects on sieve to remove lumps – use SS spatula / soft nylon brush.
4. For hygroscopic materials, ensure room temperature/RH are within limits to avoid clogging.

8.4 In-Process Checks (Typical)

• Verify at defined intervals (e.g. start, middle, end, change of container):
  • Correct sieve size in use.
  • No visible foreign particles.
  • No mesh damage or displacement.
  • Material identity and container labels correct.

Record observations in BMR / equipment log, as applicable.

9.0 COMPLETION OF SIFTING

1. Once all material is fed, allow machine to run for sufficient time so that:
   • No more material is seen on sieve surface.
   • Discharge flow of fine material has stopped.
2. Stop feeding, close feed port and let machine run for 1–2 minutes to clear residue.
3. Press STOP button.
4. Wait until the machine comes to a complete stop.
5. Collect:
   • Sifted material container(s) – label as “SIFTED MATERIAL”.
   • Retained material (oversize) – label as “REJECT / OVERSIZE” and handle as per SOP.
6. Record yield of sifted material and quantity of rejected material in BMR.

10.0 SHUTDOWN & POST-OPERATION ACTIVITIES

10.1 Immediate Post-Operation

• Switch OFF main power supply / MCB.
• Remove any spillage around the machine using vacuum / approved cleaning method.

10.2 Disassembly for Cleaning (High level – refer detailed cleaning SOP)

1. After ensuring power is OFF, remove top cover carefully.
2. Lift and remove sieve frame and take out sieve.
3. Transfer sieve to designated washing area in a labeled container / rack to avoid damage.
4. Clean machine body, contact parts and exterior as per Cleaning SOP:
   • Dry cleaning → Wet cleaning (if applicable) → Final drying.
5. Inspect that:
   • No product residue is visible.
   • No damage to parts.
6. Affix “CLEANED” / “READY FOR USE” status label with date, product and signature.

11.0 SPECIAL PRECAUTIONS

• Use dedicated / product-wise sieves, if required by cross-contamination risk assessment.
• For highly potent / sensitising materials, follow additional containment and PPE as defined in specific SOPs.
• Never change sieve size without authorised instructions (MFR / BMR / deviation).
• In case of:
  • Unusual sound, excessive vibration, or smoke / smell,
  • Immediately stop machine, inform Production & Engineering, and record incident.

12.0 DOCUMENTATION

• Record the following in BMR / Equipment Logbook:
  • Date, Product name, Batch No.
  • Equipment ID.
  • Sieve size and Sieve ID.
  • Start & stop times of sifting.
  • Quantity of material sifted, quantity rejected.
  • Any abnormalities / interventions.
  • Operator and checker signatures.