SOP on Procedure for operation and cleaning of unit dosage sampler

SOP on Procedure for operation and cleaning of unit dosage sampler

Precision and accuracy are paramount In pharmaceutical manufacturing, Ensuring that each dosage of a medication contains the correct amount of active ingredient is essential for both patient safety and regulatory compliance. To achieve this level of accuracy, pharmaceutical companies rely on various tools and technologies, one of which is the unit dosage sampler.

Unit Dosage Sampler

A unit dosage sampler, is a specialized device used in pharmaceutical quality control processes. Its purpose is to collect samples of finished pharmaceutical products, like tablets, capsules, or vials, to verify the content uniformity and quality of the medication.

Silent Features of Unit Dosage Samplers:

1. Precision: Unit dosage samplers are designed with precision to extract a precise and representative sample from a larger batch of pharmaceutical products. This precision is crucial for accurately assessing the content uniformity of the drug.
2. Automation: Many modern unit dosage samplers are automated, which helps reduce human error and ensures consistent sampling procedures. Automated samplers can be programmed to collect samples at specific intervals or based on predefined criteria.
3. Sterility: In pharmaceutical manufacturing, maintaining sterility is essential. Unit dosage samplers are often constructed with materials that can be easily sterilized, and they are designed to minimize the risk of contamination during the sampling process.
4. Compliance: Unit dosage samplers are designed to meet regulatory requirements and guidelines set by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with these regulations is crucial for pharmaceutical manufacturers.

Unit Dosage Samplers Working Principle:

A unit dosage sampler can vary depending on the specific design and manufacturer. A general overview of how they typically work:

1. Sample Collection: The unit dosage sampler is positioned to collect samples from the production line or batch. This can involve extracting individual tablets, capsules, or vials, or taking a sample from a continuous production process.
2. Sample Size: The sampler is set to collect a specific quantity of samples, which may be based on regulatory guidelines or internal quality control standards.
3. Documentation: Data regarding the collected samples, such as the batch number, date, and time of collection, is recorded for traceability.
4. Analysis: The collected samples are then analyzed to determine the content uniformity, which involves assessing the concentration of the active ingredient and other relevant quality parameters.

Benefits of Unit Dosage Samplers:

1. Quality Assurance: Unit dosage samplers play a critical role in ensuring that pharmaceutical products meet quality standards, reducing the risk of delivering subpar medications to patients.
2. Regulatory Compliance: By using samplers that adhere to regulatory guidelines, pharmaceutical companies can demonstrate compliance with industry standards and government regulations.
3. Cost Savings: Early detection of quality issues through sampling can prevent the need for costly recalls or production delays, ultimately saving money.

OBJECTIVE

To lay down the procedure for operation and cleaning of unit dose sampler.

SCOPE

This SOP shall be applicable for IPQA area in Quality Assurance.

RESPONSIBILITY

In process Quality Assurance Executive /Officer

ACCOUNTABILITY

Head Quality Assurance

PROCEDURE FOR OPERATING

Check the Status label of the sampler.

Remove the polythene film covered to the sampler.

Check the conical end piece attachment to the outer tube.

Take out the inner shaft from outer tube and insert three dies into the die receiving cavity as per sampling plan of the respective product

Insert the solid blank dies in the remaining cavities.

Turn the inner shaft at slot 2 in closed position.

Insert the sampler in to the material to be sampled.

Turn the inner shaft at slot 2 to open position and let the material filling to the first set of dies.

Turn the outer tube to close the dies

Pull the inner shaft up to slot 1 position.

Remove the individual dies by pushing them from the die receiving cavity on the inner shaft using the die retrieval tool provided with the sampler and empty the powder onto the butter paper and transfer the powder into  pre labeled  polybags and seal.

PROCEDURE FOR CLEANING

After completion of sampling, label it as ‘to be cleaned’ and keep in washing area.

Remove all the dies, slots and inner shafts from the outer shaft.

Clean the above parts with soft water at initial stage. Finally rinse with purified water.

Wipe off with lint free cloth before placing under hot air.

Visually inspect the above parts, if satisfactory reassemble them.

Finally place the sampler in fresh polythene film and label it as ‘ready for use’.

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