We can assist you when the cleaning validation masterfile is being created. We always take into account the current legislation and guidelinesmore
Currently the relevant documents for Cleaning Validation are:
- PIC/S PI 006-3
- Annex 15 EU-GMP - Guideline
- Annex 2 EU-GMP - Guideline (manufacture of biological medicinal products for human use)
- FDA - Guide to Inspections Validation of Cleaning Processes
- ICH - Guideline Q7A GMP for active ingredients, (adopted in 2001 as Annex 18 EU-GMP-Guideline, currently part II of GMP-Guideline)
We can investigate with you, your 'Worst-case substances' and help implement the cleaning results at your plant so improving operating efficieny and reducing the overall time and effort spent on validation.more
- We divide your products into groups similar to their ingredients and cleaning behaviour. These groups are examined to discover the worst case scenario.
- From your product portfolio, you identify together with us the 'Worst Case Substances', which represent the group for a joint validation.
- Based on our cleaning knowledge and technical experience with these multiple residues and ingredients we can identify their removal dynamcis as a function of temperature, time and chemistry. Using our expertise we can interperet these results into a cleaning plan.
Based on the LD50 values we provide for all our Cosa products, you can calculate product residue limits and select the most suitable swab and analytical methods.more
- According the LD50 oral/rat-values of the applied cleaning chemicals, we specify appropriate limits and adapt them to the sampling model. We take into account the different the rates of recovery.
- Would you like to assure these limits, by having a long term guarantee on the formula of the cleaning product?
- Would you like the details of the product formula?
To date we have validated TOC, Conductivity and HPLC analytical methods. You can transfer these and validate them for your needsmore
- Are you looking for validated methods for detection?
- Are you inerested in method transfer e.g. for TOC or Conductivity detection?
- We offer validated TOC and Conductivity SOP's including the procedure for sample preparation.
- Do you prefer Photometric or HPLC detection methods?
- Together we can select the most appropriate swab materials while taking in account possible interferences and the sampling method
- Based on the construction geometry of equipment, as well as the parameters of the cleaning procedures, we define representive and critical points for sample-taking.
We can provide an alternative to the Riboflavin testing method.more
- Do you still check the quality of your clean based on the Riboflavin testing?
- Would you prefer to get clear answers on the cleaning mechanics of your equipment?
- Are you looking to optimise the cleaning procedures for your installations with regards to the mechanical parameters and operational efficiency?
- Ask us; we have developped the Aquanta Blue procedure, which shows
- clearly the results of mechanical parameters of cleaning
- gives testimonial evidence for its qualification.
- In co-operation with partners we can achieve an acertained optimization of your prodecures.
We can provide consultation during cleaning trials at your site; to help optimise your procedure and achieve the highest level of operational efficiency, while simultaneously ensuring a robust process is in place.more
- Would you like assistance from our industry applications specialists on your cleaning procedures?
- Do you require specialists who know about the specific pharmaceutical requirements relevant at your site?
- Are you producing high risk active ingredients and looking for reliable methods of decontamination?
- Do you need to clean isolators?
Are you interested in holistic cleaning methods that not only consider the optimisation of your equipment, but also the safety aspects and overall cleaning efficacy.
- Are you seeking an alternative to the riboflavin method?
- You require your validated procedures to be cost effective.
- We will support you in the consideration and evaluation of all the cleaning parameters to create the cleaning SOP for:
- recovery rates
- analytical methods
- CIP or manual cleaning procedures