Cleaning Validation Protocol for Cannabis Certificate Programs

1
Cleaning Validation Protocol for Cannabis
Certificate Programs
Allyson Galinski

• Purpose
• To validate that the Sanitation Standard
  Operating Procedure (SSOP) for BuckMaster Pro
  Trimmer Series for the production of trimming dry
  and wet cannabis is sanitized effectively and
  consistently.
• Scope
• To eliminate all chemical and microbiological
  contamination between batches, or after
  completion of any activity described under
  Cannabis Regulations, Part 5.
• The validation study will be conducted in the
  Cannally Ltd. production facility for the
  cleaning and sanitation procedure for the
  BuckMaster Pro Trimmer.
• 3.0 Definition
• Technical terminologies used in cleaning
  validation
• Responsibilities
• Quality Control
• Quality control is responsible for the testing of
  the validation samples and compilation of
  results.
• Testing of the samples during the study to
  conduct chemical, microbiological testing.

2

• 4.1.3
• Responsible Person (RP)
• Review and approve sanitation protocol.
• Take samples for testing of contaminants.
• Execution of all data must be collected.
• Preparation and review of protocol and report.
• Validation Person
• Responsible for writing validation protocol.
• Reviewing, approving and executing validation
  protocol.
• Properly write validation report.

5.0
Cleaning Validation Plan
MIRCO SAMPLE DETERGENT SAMPLE PRODUCT RESIDUE SAMPLE REASON
3
Bucking Plates X3 X3 X3 Difficult to clean
Rollers X3 X3 X3 Difficult to clean
Material Holders X3 X3 X3 To rep
Cross Tube X3 X3 X3 To rep

• Tests that need to be performed to control the
  process are
• Microbiological residue
• Detergent Residue
• Product Residue
• Rinse Sampling
• In this method, a measured area of clean surface
  is rinsed or washed with solvent and the solvent
  is collected and tested for traces of
  contaminants. Rinse samples allow sampling for a
  large surface area and of inaccessible areas
  that cannot be routinely disassembled. A direct
  measurement of the residue or contaminant in the
  relevant solvent should be made when rinse
  samples are used to validate the cleaning
  process. The compound to be sampled should be
  soluble in solvents.
• Rinse samples must be used in combination with
  other sampling methods. Equipment is washed with
  water and with organic solvents (usually heated
  up to the boiling point to clean the head space
  of the equipment) and the final washing solution
  is analyzed.
• Direct Surface Sampling
• This sampling method involves an analytical
  instrument directly applied to the cleaned
  surface. It includes contact plating and
  swabbing. Contact plates are useful for sampling
  flat, smooth surfaces. In addition, locations
  should be well accessible.
• This sample should be taken according to the
  following procedure
• Put on gloves and all protective equipment.

4

• Using one side of the swab, collect a sample in
  an area that is greater or equal to 1 square foot
  by vigorously rubbing the swab with firm
  pressure approximately 10 times in a vertical up
  and down motion following a Z pattern.
• Turn swab to opposite side and swab approximately
  10 times in a horizontal, side to side motion
  over the surface area being sampled.
• Swab diagonally using the same swab surface side
  as used in the vertical swabbing.
• Swab approximately 10 times in the sampling area
  until the opposite side's bottom corner has been
  sampled.
• Upon completion of sample collection, return swab
  into corresponding vial.
• Label vial with appropriate information. If
  immediate testing cannot be performed, place
  samples in the refrigerated area.
• Take 3 (3 for micro test, 3 for chemical tests
  and 3 for retained samples) from the entire batch
• from beginning, middle and end of the
  processes/containers.
• Place the samples in a pre-labelled container
• Send the samples to both micro and chemistry lab
• Swab Sampling
• This method is based on the physical removal of
  residue left over on a piece of equipment after
  it has been cleaned and died. A swab wetted with
  a solvent is rubbed over a previously determined
  sample surface area to remove any potential
  residue. Afterwards, the sample is then extracted
  into a solvent in which the contaminant active
  ingredient residue is soluble. The amount of
  contaminant per swab is then determined by an
  analytical method of adequate sensitivity.

6.0
Testing Acceptance Criteria
6.1 For the dissolution method, relative standard
deviation (RSD) of the six analyses shall be no
more than 5 for release above 85 and not more
than 10 for release before 85. 7.0 Reference A
ttachment 1
5
Table 1 Cleaning Validation Sampling Form
Sampling Product Detergent Micro Performed by

• Learn more about Cleaning Validation through the
  following Diploma and Cannabis Certificate
  programs
• Certificate Program
• Sanitation and Testing Requirements for Cannabis
  Production Cannabis certificate programs
• Diploma Programs
• Cannabis Quality Control and Quality Assurance
  Industrial Cannabis Production Technology
• About Us
• NACPT is a leading career college in Canada that
  provides in-depth skill training in
  pharmaceutical, cannabis, business, technology
  and related fields to maximize the job and
  business opportunities within the target
  industries. NACPT has offered specialized
  Certificate, Graduate and Postgraduate diploma
  programs in the pharmaceutical and cannabis
  industries for over ten years. We also offer
  various cannabis skills training and business
  incubation programs in the related industries.
  As a college with affiliations of highly
  reputable organizations, NACPT

6
provides analytical testing, consulting services
and research development in the
pharmaceutical, cannabis and other
sectors. Check out all our cannabis diplomas and
cannabis certificate programs to gain in-depth
knowledge from industry professionals. Visit us
at www.NacptPharmaCollege.com for more
information. For those interested in learning
more about cannabis programs, careers and events
at NACPT, contact us today Inquiry 1 416 412
7374 Call/Text 1 647 998 7374 E-mail
info_at_nacptpharmacollege.com Website
www.NacptPharmaCollege.com