Chemical SOP
Microbiology SOP
Warehouse SOP
Manufacturing SOP
Information technology SOP

DECODING SOLVENT DISPENSING AREA IN PHARMA (PICTORIAL)

The Solvent Dispensing Area (SDA) is a controlled and ventilated workspace designed specifically for:

  • Receiving, measuring, and dispensing of volatile or flammable solvents (e.g., methanol, ethanol, acetone, IPA, toluene).
  • Transferring solvents from large containers (drums or barrels) into smaller, accurately measured quantities for use in production or analytical processes.

Key Design Elements:

ElementPurpose
Dispensing booth / laminar flow hoodProvides local exhaust ventilation to capture solvent vapors. Often equipped with flameproof lighting and explosion-proof fittings.
Anti-static flooring and groundingPrevents static discharge during solvent transfer, reducing explosion risk.
Pressure differential controlMaintains negative pressure relative to adjacent clean areas to contain vapors.
Exhaust and supply air ductsEnsures a minimum number of air changes per hour (e.g., 20–25) and directs solvent fumes to a safe exhaust system.
Safety shower and eye wash stationProvides immediate decontamination in case of accidental exposure.
Solvent-resistant floor drainsSafely collect accidental spills into solvent collection tanks.

Safety Features:

  • Flameproof Light.
  • Continuous exhaust ventilation to keep vapor concentrations below 25% of LEL (Lower Explosive Limit).
  • Automatic fire detection and suppression system (CO₂ or dry powder).
  • Earthing and bonding for all metal drums, vessels, and transfer lines.
  • Solvent vapor detectors with alarm and interlock features.

Environmental Controls:

  • Temperature: typically 20–25°C
  • Relative humidity: ≤ 60%
  • Air pressure: Negative to adjacent areas
  • Air filtration: HEPA filtered air if part of a cleanroom-grade operation

Example Workflow:

  1. Solvent drums brought from quarantine → to dispensing area.
  2. Drum connected to earthing line and grounded dispensing pump.
  3. Solvent dispensed under local exhaust ventilation.
  4. Measured volume transferred into clean, labeled stainless-steel or HDPE containers.
  5. Area cleaned, and documentation completed before next batch.

References:

  • WHO GMP / EU GMP Vol. 4
  • ISPE Guidelines
  • NFPA (National Fire Protection Association) standards
  • Schedule M (India)
  • OSHA & ICH Q7 (for APIs)

Leave a Reply

Your email address will not be published. Required fields are marked *

error: Content is protected !!