Cleaning Validation for Packaging Equipment:

This is a continuation of last month’s Cleaning Memo. In that Cleaning Memo I discussed the criticality of cleaning for primary packaging equipment.

That this is important is evident from the fact that the principle involved (non-uniform contamination of the next batch) is mentioned in the FDA cleaning validation guidance. This month I will focus on issues related to limits and worst-case challenges. As discussed last month, one issue that makes primary packaging equipment critical is that it is possible that residues on some or all surfaces of the primary packaging equipment may preferentially transfer to a small portion (such as the first portion) of the next product packaged. It would be prudent to set limits based on this worst-case assumption (that transfer of residues can preferentially occur into a small portion of the next batch).

Author(s):
Destin A. LeBlanc Cleaning Validation Technologies Technical Consulting Services
Journal:
Cleaning Memo for APRIL 2005.

8 comments:

dasbiswajite said...

Our professionals use state-of-the-art software, including such modeling programs as AutoCAD, SolidWorks, and Pro Engineer to design and analyze your planned mechanisms prior to manufacturing actual prototypes.


automateandvalidate

jackbroobgm said...

The ability of prerequisites to streamline the execution of a qualification,
with the added bonus of the ways that they benefit a quality system,
demonstrates the value of incorporating prerequisites into an equipment qualification.This service saves you time and money,
as you can review these digital representations.

equipment validation
labview programming
software validation

Kevin Petter said...


Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects.
It is a critical success factor in product approval and ongoing commercialization.
This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision,
also provide the answer of question like why to do, when to do and how to do it.
This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process.
Quality is always an imperative prerequisite when we consider any product.



equipment validation

Andree Symond said...


Any single group must be subjected to the 3 validation cleaning requirement,
except if a rationale is recorded and also approved by the Standard Authority
which the worst-case product of one group is clearly a worst-case product for every one of the groups.
Software validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.


equipment validation

Andree Symond said...

The ability of prerequisites to streamline the execution of a qualification,
with the added bonus of the ways that they benefit a quality system,
demonstrates the value of incorporating prerequisites into an equipment qualification.This service saves you time and money,
as you can review these digital representations.

equipment validation

Devid Woody said...


Written cleaning procedures should be established. Attention should be addressed to dedicate certain equipment to specific products,
such as fluid bed dryer bags and to residue originating from the cleaning detergent or solvent themselves.
By packaging equipment I am referring to primary packaging equipment.


equipment validation

Lee Ghirale said...

We can then execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution
These kind of post are always inspiring and I prefer to read quality content so
I happy to find many good point here in the post, writing is simply great, thank you for the blog.

equipment validation

Jasos Angla said...

we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that
critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.


equipment validation