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Qudos - Helping with your compliance needs

October 2023

Educational Presentations & Information

Cleaning, and Cleaning Validation

Cleaning is an essential step in nutraceutical, pharmaceutical and food production, because it helps to remove contaminants from equipment and rooms and ensures the safety and integrity of the finished products.

 

Contaminants may come from a variety of sources, such as the previous product, lubricating greases, and oils, air or waterborne microbials, airborne dusts and even detergents and sanitisers used during the cleaning process.

 

Cleaning should always follow an established documented method, which must be easily followed so that it can be repeated in the exact same manner each time and ensure that cleaning is effective every time. 

 

Cleaning validation helps us confirm that the cleaning method is effective, by checking for the presence of contaminants. 

Cleaning validation is generally performed on the worst-case scenario looking at several factors:

  • How many different products are manufactured on the line, and how often are each of the products produced.
  • How potent, toxic, or hazardous are each of the materials on the line (including finished goods, raw materials, manufacturing aids, detergents, and sanitisers), and what is the permitted daily exposure level of the materials.
  • How many different sources of raw materials are used.
  • How easy is the line to clean, and each part of the line.
  • Is the clean a manual, automated or a hybrid approach.
  • How susceptible is the line and product to microbial contamination.

The validation must be repeated enough times (normally a minimum of 3) to give assurance that when using the cleaning method, you will always have end up with an acceptable level of carry-over of any contaminants without the need to test for them each time. 

The more manual a process the more difficult it is to give assurance that a low level of validation runs is considered suffice to give this assurance.

 

Cleaning validation can be very confusing.  Fortunately, there is a lot of guidance that can be used to generate a good protocol.  Guidance includes:

Upcoming Events

Medsafe Industry Day

Medsafe are hosting a meeting for applicants, sponsors and consultants who submit and manage New and Changed Medicines Applications.  Make sure you register by 20 October 2023.

9 November 2023

New Zealand Institute of Healthcare Engineering Conference

The NZIHE conference provides engineers the opportunity to network with those in the industry.

14-15 November 2023

News

TGA

02/10/2023

No News is Good News

Keep this page bookmarked as the new section will be updated during the month.

Medsafe/MoH

02/10/2023

Maximum number of Approved Smoked Tobacco Products

Currently there are approximately 6,000 retail stores selling smoked tobacco products in New Zealand.  Under new legislation this will be restricted to no greater than 599 outlets, with the aim to make Aotearoa smoke-free.