SOP on Cleaning of Dry Syrup Filling Machine

SOP on Cleaning of Dry Syrup Filling Machine

SOP on Cleaning of Dry Syrup Filling Machine

SOP on Cleaning of Dry Syrup Filling Machine

1.0 Objective : To describe a cleaning procedure for the dry syrup filling machine.

2.0 Scope: To ensure that the equipment is clean and free from any starting materials of previous batch or product residues.

3.0 Responsibility :

3.1 It is the responsibility of the operating staff to clean the equipment.

3.2 Production Chemist to ensure that procedure is followed.

4.0 Materials & Equipment :

4.1 Cleaning agent: Teepol or liquid soap.

4.2 Mops / brush / lint free cloth

5.0 Procedure

5.1 Remove visible material from the machine with the help of a jet of compressed air.

5.2 Dismantle the hopper, nozzle etc. and place in a plastic tub.

5.3 Take the dismantled parts to washing area and clean them with 10 liters of boiled tap water and drain the washings.

5.4 Prepare a Teepol solution (10ml à 10 liters water) or liquid soap (50gm à 5 liters water) and clean the surfaces of all the dismantled parts by mopping.

5.5 Wash all the dismantled parts by running tap water for 5 minutes.

5.6 Wash all the dismantled parts with 5 liters of purified water.

5.7 Finally rinse all the parts with previously boiled purified water and drain it completely.

5.8 Send the wash water for analysis of residual active ingredients of previous product.

5.9 Let all the machine parts dry in air or dry with a clean lint-free cloth, reassemble in the reverse order of dismantling and put a label “Clean” or “Ready for use”.

Frequently Asked Questions (FAQs) with Answers

Q1: What is a dry syrup filling machine? A1: A dry syrup filling machine is a specialized equipment designed for accurately filling dry powder or granular pharmaceutical formulations into containers, such as bottles or vials. It is commonly used in the pharmaceutical industry to streamline the packaging process.

Q2: Why is it necessary to clean the dry syrup filling machine? A2: Cleaning the dry syrup filling machine is essential to maintain product quality, prevent cross-contamination between different batches, and ensure compliance with hygiene standards. Regular cleaning also helps in extending the machine’s lifespan and preventing issues related to residue buildup.

Q3: Who is responsible for cleaning the dry syrup filling machine? A3: The operator who is responsible for operating the dry syrup filling machine is also responsible for its cleaning. Proper training and adherence to the cleaning procedure outlined in the SOP are crucial for effective cleaning.

Q4: What materials are required for cleaning the dry syrup filling machine? A4: The materials required include approved cleaning solution, lint-free wipes, brushes (soft and medium), compressed air source, and Personal Protective Equipment (PPE) such as gloves and goggles.

Q5: How often should the dry syrup filling machine be cleaned? A5: The frequency of cleaning depends on the production schedule and the nature of the products being processed. Generally, it is recommended to clean the machine between different batches or products to avoid cross-contamination.

Q6: What is the importance of sanitization in the cleaning process? A6: Sanitization is crucial in the cleaning process to eliminate any remaining microorganisms or contaminants on the machine’s surfaces. This step helps ensure the production of safe and high-quality pharmaceutical products.

Q7: Can I use any cleaning solution for the dry syrup filling machine? A7: No, only approved cleaning solutions specified by the company or recommended by the machine’s manufacturer should be used. Using unapproved cleaning agents may damage the machine or leave harmful residues.

Q8: How should I document the cleaning activities of the dry syrup filling machine? A8: Record the cleaning activities in a designated logbook, including the date, time, and the person performing the cleaning. Note any observations or issues that require attention. Proper documentation is essential for traceability and compliance.

Q9: Is it necessary to conduct any tests or checks after cleaning the machine? A9: Yes, it is advisable to perform final checks after cleaning, including a visual inspection to confirm cleanliness, ensuring safety guards and covers are in place, and conducting any additional tests or checks required before restarting the machine.

Q10: What should I do if I encounter any issues during the cleaning process? A10: If any issues arise during the cleaning process, document them in the logbook and report them to the relevant personnel or supervisor. It’s important to address and resolve issues promptly to maintain the machine’s operational efficiency.

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