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Cleaning can be defined as the removal of residues from previous batch, other residues, and traces of cleaning agents. There are several mechanisms associated with cleaning of equipment. The mechanisms involved can be mechanical action, chemical action between the residues and the cleaning agent.

The selection of cleaning agent and mechanism involved in cleaning is largely dependant on the process residue to be cleaned.

Cleaning Mechanisms

The cleaning mechanism totally depends on the selection of cleaning agent and type of residue to be cleaned. Following can be the one of the methods involved in cleaning of residues,

  • Dissolution
  • Saphonification
  • Wetting
  • Emulsifying

Dissolution

Dissolution is the process by which a solid or liquid forms a homogeneous mixture with a solvent or solution. This can be explained as a breakdown of the crystals into individual ions, atoms or molecules and their transport into the solvent

The mechanism involved in this type of cleaning is solubility of the residue in the cleaning agent or solvent. The monobasic buffers i.e. sodium chloride are soluble in cool and hot WFI.

Ethylene glycol butyl ether is soluble in water as well as oil is also used in solubilizing agent. Chelating agents and builders are added to the formula to keep water hardness from interfering with the cleaning process.
Rate of dissolution is depend on,

  • Nature of solvent or residue to be dissolved
  • Temperature of solvent
  • Presence of mixing
  • Area of contact
  • Presence of inhibitors

Saphonification

Saponification can be defined as “hydration reaction where free hydroxide breaks the ester bonds between the fatty acids and glycerol of a tri-glyceride, resulting in free fatty acids and glycerol”, which are each soluble in aqueous solutions.

This process specifically involves the chemical degradation of lipids, which are not freely soluble in aqueous solutions. Heat treated lipid residues are difficult to remove than non-heat residues due to polymerization.

Saphonification plays a critical role in cleaning lipids which are present in the areas of process involving cell growth and cell processing i.e. Bacterial fermentation, Cell disruption process

Wetting

Wetting can be defined as a process “involves the lowering of the surface tension of the cleaning solution, thus allowing it to better penetrate residues that are adhered to equipment and piping surfaces”. Wetting agents, or surfactants, are often used in relatively small amounts and they can substantially reduce the quantities of cleaning agent (in this case, alkali) required for residue removal.

Advantages of Wetting

  • Lowers the surface tension of the cleaning solution
  • Allow better penetrate residues which are adhered to equipment
  • Used in small amount
  • Sticky residues which are hydrophobic in nature get easily removed

Water acts as a solvent that breaks up soil particles after the surfactants reduce the surface tension and allow the water to penetrate soil (water is commonly referred to as “the universal solvent”).

Emulsifying

Emulsifying and suspending agents are often used to keep residues from precipitating by providing “hydrophobic groups” onto which hydrophobic areas of residues can associate, thus preventing them from associating with other residues and forming larger particles which are likely to leave solution.

These agents also typically have “hydrophilic groups” which keep them very soluble in aqueous solutions of moderate to high ionic concentrations. Emulsifiers increase the capacity of a cleaner to emulsify non-soluble compounds in the cleaner. i.e. anionic soap surfactants, cationic surfactants, neutral surfactants

Advantages of Emulsifying agents,

  • Prevent association of residues
  • Allow the residue to precipitate and not allow thdse residue to redeposit on surface

Learn more about Cleaning Validation

If you would like to learn more about Cleaning Validation click here to enter our cleaning validation forum.

What do you think about this article? Have your say by leaving your comments below.

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  • g srinivasarao

    plz update the knowldge.

  • g srinivasarao

    plz update the knowldge.

  • http://www.cipla.cpm Pramod Pandey

    hi

    i had query related area calculation for the cleaning validation, how we have calculate and how we have determine the area and acceptance limit.

  • http://www.cipla.cpm Pramod Pandey

    hi

    i had query related area calculation for the cleaning validation, how we have calculate and how we have determine the area and acceptance limit.

  • kamlesh gupta

    how we will decided the cleaning validation if the least soluble product coming continues four times.

  • kamlesh gupta

    how we will decided the cleaning validation if the least soluble product coming continues four times.

  • kamlesh gupta

    how we will decides sampling quantity of granules and sterile samples during the process validation

  • kamlesh gupta

    how we will decides sampling quantity of granules and sterile samples during the process validation

  • http://None Nikhilesh Bhana

    Good Knowledge.

  • http://None Nikhilesh Bhana

    Good Knowledge.

  • ananda tarate

    can we use sodium lauryl sulphate as a cleaning agent ?if yes,how the process takes place ?

  • ananda tarate

    can we use sodium lauryl sulphate as a cleaning agent ?if yes,how the process takes place ?

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Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability.

Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

This module is taken from our course on Supplier Qualification.

 

About Us

Learnaboutgmp is a cloud based learning management system (LMS) designed specifically for life science and regulatory organizations. Our LMS contains the courses you need to help you achieve regulatory compliance. With new courses published every month and existing courses updated in line with regulatory changes we are your true continuous learning platform.

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Choosing the correct software for your organisation is a tricky task and even more so when you are working in a regulated environment.

It’s one thing finding a great software package but if the vendor does not take their quality system seriously this could have a dramatic effect on the evolution and robustness of the solution.

They need to take their quality efforts as seriously as you take yours otherwise product quality and patient safety could be compromised.

An overall quality audit should be performed on each vendor before a decision is made, below are a list of questions that you could ask each vendor specifically on their quality system.

If the software vendor does not take their Quality System seriously you need to walk away.

Quality System Questionnaire

  1. Does the company have an established and Documented Quality System?
  2. Does the Quality System adequately reflect the client’s quality engineering policies?
  3. Is the responsibility for Quality defined (SOP)? What are their qualifications?
  4. Is Quality System documentation adequately controlled in terms of review, approvals and distribution
  5. Is the QS documentation regularly updated and otherwise maintained appropriately? (frequency)
  6. Are there procedures for reviewing the performance of the QS e.g. Internal Audit, Management Review?
  7. Are there training procedures and Job specifications? Are these adequate for the Maintenance of the QS
  8. Is there a Quality Plan for the Design, Development and Implementation of the products?
  9. Do the company use Sub Contractor’s?
  10. Do the company have control over any Sub Contractor’s QS? e.g. Vendor Assessment, Specification, Documentation review and approval?
  11. Do the company have access to relevant Sub-contractor Quality documentation?
  12. Is Sub Contractor’s Quality System compatible with the previous questions of this section?
  13. Have the Sub Contractors been audited? Review the report?
  14. Has accreditation/registration been achieved for: BS 5750 Pt. 1 or 2, TickIT, ISO 9000, Other (name
  15. Does the company operate to GAMP for computer systems?
  16. Are there SOPs for QC? Is there a release procedure?
  17. Is there an out-of-specification procedure?

Choosing the correct software application for your organization is a very tricky task and one that takes alot of upfront planning in order to make the correct choice.

The task has even got more difficult with the emergence of cloud based technology and how that impacts the overall validation process.

Remember to outline your requirements clearly and get buy-in from the other business owners.

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