To clean and sanitize the Closed Loop Extraction System in preparation for future runs. This will prevent contamination of future batches and keep gaskets fresh. Cleaning and sanitizing the system will also maintain the equipment, reduce corrosion and degradation of components within the system and protect the longevity of the system for use.
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Sample of a Standard Operating Procedure (SOP) for Cleaning and Sanitizing Cannabis Facilities
1. Sample of a Standard Operating Procedure (SOP)
for Cleaning and Sanitizing Cannabis Facilities
Lynn McAllister
1.0 Purpose of a Sanitation SOP
To clean and sanitize the Closed Loop Extraction System in preparation for future runs. This will
preventcontaminationof future batchesandkeepgasketsfresh.Cleaningandsanitizingthe system
will alsomaintainthe equipment,reducecorrosionanddegradationof componentswithinthe system
and protect the longevity of the system for use.
2.0 Scope
The scope of this SSOP is to ensure the system maintains compliance up to sanitary standards
determined by LMc LLC. This SSOP, SSOP-002, is only applicable to the Closed Loop Extraction
Equipment within the LMC LLC facility. Only Authorized personnel are to clean and sanitize the
equipment in this SSOP.
3.0 Material / Equipment
3.1 Extraction Equipment – 5lb Closed Loop BHO extractor
Fig 3.1.1 5lb Closed Loop BHO extractor Fig 3.1.2 Butane flow path in System
2. 3.1.1 Image of BHO 5LB Closed Loop Extractor with all parts excluding the LP
3.1.2 Image of new, mixed and recycled butane and flow paths in the BHO extractor system.
3.2 Diagram of standard components used in a Closed Loop Extraction System.
3. 3.2.1 3" material tube lid.
3.2.2 Manifold - Blue - Left gauge:
● Blue readings indicate the measure of vacuum.
● Green readings indicate the measure of pressure.
3.2.3 Manifold - Red - Right gauge:
● Indicates High Pressure gauge
3.2.4 2" stainless steel & PTFE ball valve and stainless steel hoses.
● 2 qty 3/8" hose
● 3 qty ¼" hose
● 1 qty ¼" hose with 90 degree angle at one end.
3.2.5 LP Tank - Liquefied Petroleum gas tank.
3.2.6 Vacuum pump with ¼" flare fitting.
4. ● Used to remove all of the air before every extraction.
3.2.7 Solvent recovery pump
● Driving force that moves the solvent throughout the system.
3.2.8 Filter dryer - Used to remove moisture from the system
● Water contamination can lower yield and degrade products.
● Arrows on the filter must always face towards the recovery pump.
● Stainless fitting is for the 3/8" recovery line
● Brass coupler connects the dryer to the recovery pump.
3.2.9 3" x 48" material tube
● Where plant material goes during the extraction.
● Holds up to 5lbs of botanical plant material.
3.2.10 Collection Chamber - 10" x 12"
● Collection chamber lid with sight glass
● 4 ports and 2" barrel.
● Where extract will finish.
3.3 Personal Protective Equipment:
3.3.1 Gloves – To protect hands from solvents and prevent oils from remaining on
equipment.Highlyresistanttohydrocarbonoils,fats,detergentsandsolvents,usedfor
industrial applications that require a tough disposable glove.
3.3.2 Hydrocarbon Mask – To protect lungs from any residual solvents or eyes from any
potential projectiles when disassembling/assembling the system.
3.3.3 Nomex Coat – For body protection when working with solvents and/or potentially
explosive chemicals. This coat is flame resistant and resists ignition.
3.3.4 Hair and/or beard net – Full coverage hairnet that prevents contamination during the
cleaning and sanitizing process.
3.3.5 Booties – Preventtrackingindirt and debrisand potential forcross-contaminationinto
the production facilities area.
3.4 Cleaning Equipment:
3.4.1 Heavy dutywipers- Use tocleanheavymachinery,prepsurfaceswithsolventsandwipe
down shop tables.
3.4.2 Explosion Proof Fan – An Exhaust Fan that is a ventilation device with sufficient
protection to contain an internal blast on exposure to a combustible airstream.
3.5 Cleaning Materials:
3.5.1.1 Detergent: Oakite 33 - Form: Liquid
Operating Temperatures: 80°F to 140°F (60°C)
5. Oakite 33 is a liquid, acidic compound used for removing light grease, oils, shopdirt,
flux, rust, oxides, scale on steel, stainless steel and aluminum.
3.5.1.2 Sanitizer: 70% Isopropyl Alcohol - 3.78 L Bottle Uline
Operating Temperatures: Room Temperature.
70% isopropyl alcohol is the most commonly used disinfectant in pharmaceutical
industries. It acts as a disinfectant killing all surface microorganisms, It is used to
disinfect hands and equipment surfaces in pharmaceutical environments.
3.5.1.3 Sanitizer: Quat 10 Disinfectant
Operating Temperatures: Room Temperature.
Quat 10 is designed specifically for hospitals, food processing plants, dairies,
restaurants, bars, animal quarters, kennels and institutions where disinfection,
sanitization and deodorization is of prime importance.When use as directed, this
product is formulated to disinfect precleaned hard surfaces and deodorizes odors
caused by microorganisms.
4.0 Related Standard Operating Procedures
4.1 SSOP-001 – Sanitization testing for QA.
4.2 SSOP-004 – Personnel Health and Hygiene practices.
4.3 SOP-010 – Post Extraction Procedure
4.4 SOP-011 – How to test for leaks using the BHO Extractor after assembly.
4.5 Cannabis Regulations SOR/2018-144
4.5.1 Equipment - Section 86 (1)
4.5.2 Sanitation program Section 87 (1)
4.5.3 Removal and disposal of contaminated materials and waste Section 88.9 (1)
4.5.4 Clothing, footwear and protective coverings Section 88.92
4.5.5 Preventive control plan Section 88.94 (1)
5.0 Responsibilities
5.1 Head of Laboratory:
5.1.1 Write, review and approve the procedure for SSoP.
5.1.2 Training on the procedure to the sanitation team.
6. 5.1.3 Maintain compliance of the team to procedure standards.
5.2 Key Personnel –
5.2.1 Train and understand SSoP procedure.
5.2.2 Ensure proper personal protection equipment is utilized.
5.2.3 Implement the procedure according to company standards.
5.2.4 Log any issues and report to the Head of Laboratory.
5.3 Responsible person (RP) –
5.3.1 Review and approve the procedure for SSoP.
5.3.2 Maintain compliance of the team to procedure standards.
5.3.3 Reports metrics to Health Canada as required.
5.4 Quality Assurance Person (QAP) –
5.4.1 Review and approve the procedure for SSoP.
5.4.2 Maintain regulation compliance of the team to procedure standards.
5.4.3 Reviews and makes recommendations for any changes or revision as per the Federal,
Provincial and Municipal regulatory requirements.
6.0 Cleaning and Sanitizing procedure: This occurs after every batch and is used as SSOP for daily
procedures. The same SSOP would be used for weekly or Monthly Cleaning frequencies.
Once the extractionprocessiscompleted,itisimportanttobreak downand cleanthe gear.This will
prevent contamination of future runs, as well as keepgaskets fresh. The equipment should be kept
cleananddry to maintainsanitaryconditionsandavoidcorrosion.Itismucheasiertocleanjustafter
use before surfaces dry as dried residue can be difficult to remove.
6.2 Disassembling the extractor for cleaning.
6.2.1 Safely unscrew the hose attached to the lid of the material tube.
● Always break the seal of a system by opening a valve or unscrewing a hose.
● Never start with opening a clamp.
6.2.2 Unscrew the 3/8" recovery hose from the collection chamber lid.
6.2.3 Safely exhaust the lines of any remaining solvent.
● Open the blue valve (left side) of the manifold.
7. ● Hold the ventilation duct of the Explosion Proof Fan up to the blue valve.
6.2.4 Remove the manifold from the material tube.
6.2.5 Unclamp the material tube from the reducer.
● Unscrew the double bolt clamp where the material tube meets the reducer.
● Unscrew from the top of the reducer, 3" end NOT the 2" end.
6.2.6 Unclamp material tube from the stand and remove it from the extractor.
● Place in a safe and well-ventilated area until ready to clean.
6.2.7 Remove the collection chamber if in a bucket of water and dry off the lid.
6.2.8 Unscrew the 10" double bolt clamp releasing lid from the collection chamber.
6.2.9 The extractor is now disassembled for cleaning.
6.3 Clearing the hoses of any residual solvent.
6.3.1 Take your explosion proof ventilation and place it near the valve of the blue gauge on
the manifold.
6.3.2 Open the blue gauge valve slowly releasing the solvent in the lines.
See Fig 3.1.2 for Butane flow path.
6.3.3 If youdon't ventout thishose you will enduppullingthe solventoutwithyourvacuum
pump. (This could result in a potential fire or even explosion)
6.3.4 Before finishing, weigh the tank again to know the amount of solvent recovered back
into it.
● Subtract the weightof the emptytankagainstthe currentweighttoget the weightof
solvent in the tank.
6.4 Cleaning and Sanitizing the Material Tube.
6.4.1 Hold the ventilation duct of the explosion proof fan up to the lid of the materials tube
when opening. Remember that there are residual solvents in the plant matter in the
material tube.
6.4.2 Scraping/Pre-cleaning: Scrape and rinse to remove loose residue ahead of time.
● Empty out the contents of the material tube and dispose of it in a purge chamber to
release residual gases in the plant matter.
8. ● The material tube will be coveredin lipids.Use a scrub brush to loosenthe materials
andlipidresiduepriortowashingwithdetergent.Scrubuntilthe materialtubeappears
to have loosened or for up to 1 minute.
6.4.3 Wash: Use detergent solutions to loosen and remove the remaining substance.
● Prepare Oakite 33 detergent at 10% to 50% concentrate at room temperature.
● Apply with brush scrubbing the inside of the tube.
● Use a scrubbrushtoloosenresiduefromthematerials tubeandscrubuntilvisiblyclean
or up to 3 minutes.
6.4.4 Rinse: To remove any remaining substance and detergent.
● Use waterto thoroughlyrinsethe materialtubeof the detergentandloosenedresidue.
● Rinse multiple times until visibly clean or up to 3 times.
● Let air dry before sanitizing.
6.4.5 Sanitize: To kill attached surviving bacteria and viruses that may still be present.
● Use 70% IPA to rinse and mix with 30% water to use as a sanitizing rinse.
● Rinse multiple times until visibly clean or up to 3 times.
6.4.6 Air Dry: To allow chemical sanitizers to evaporate and to prevent recontamination.
● Once Air dry proceed to Sample and Validation Testing using SSOP-001
6.4.7 Monitoring/Corrective Action:Mustbe done after the systemis cleaned,sanitizedand
air-dried.
● Perform Visual Inspection of the equipment.
● Perform ATP Detection using methods defined in:
- SSOP-002: Using Dyes to perform microbiological testing
- SSOP-003: Optical lights can identify microbiological residues.
● If particulate matter is found on any area of the machine upon inspection, repeat the
clean-up procedure as detailed above for that particular area.
● Whenever there is residue remaining, you must log it in the cleaning log-book.
6.5 Cleaning and Sanitizing the Collection Chamber.
6.5.1 Hold the ventilation duct of the explosion proof fan up to the lid of the collection
chamber when opening. Remember that there are residual solvents in the collection
chamber along with the extraction product.
9. 6.5.2 Scraping/Pre-cleaning: Scrape and rinse to remove loose residue ahead of time.
● Empty out the contents of the collection chamber and continue the extraction the
process according to SOP-010
● The collection chamber will be covered in extraction residue. Use a scrub brush to
loosenthe extractionresidue priortowashingwith detergent.Scrubuntil the material
tube appears to have loosened or for up to 1 minute.
6.5.3 Wash: Use detergent solutions to loosen and remove the remaining substance.
● Prepare Oakite 33 detergent at 10% to 50% concentrate at room temperature.
● Apply with brush scrubbing the inside of the tube.
● Use a scrubbrushtoloosenresiduefromthematerialstubeandscrubuntilvisiblyclean
or up to 3 minutes.
6.5.4 Rinse: To remove any remaining substance and detergent.
● Use waterto thoroughlyrinsethe materialtubeof the detergentandloosenedresidue.
● Rinse multiple times until visibly clean or up to 3 times.
● Let air dry before sanitizing
6.5.5 Sanitize: To kill attached surviving bacteria and viruses that may still be present.
● Use 70% IPA to rinse and mix with 30% water to use as a sanitizing rinse.
● Rinse multiple times until visibly clean or up to 3 times.
6.5.6 Air Dry: To allow chemical sanitizers to evaporate and to prevent recontamination.
● Once air dry proceed to Sample and Validation Testing using SSOP-001
6.5.7 Monitoring/Corrective Action:Mustbe done after the systemis cleaned,sanitizedand
air-dried.
● Perform Visual Inspection of the equipment.
● Perform ATP Detection using methods defined in:
- SSOP-002: Using Dyes to perform microbiological testing
- SSOP-003: Optical lights can identify microbiological residues.
● If particulate matter is found on any area of the machine upon inspection, repeat the
clean-up procedure as detailed above for that particular area.
● Whenever there is residue remaining, you must log it in the cleaning log-book.
10. 6.6 Cleaning and Sanitizing the Filter Plate.
6.6.1 Scraping/Pre-cleaning: Scrape and rinse to remove loose residue ahead of time.
● Remove all debris and physical matter using a heavy duty wipe.
● Dispose the wipe and remove residue into the proper waste container.
6.6.2 Wash: Use detergent solutions to loosen and remove stuck-on substances.
● Prepare Oakite 33 detergent at 10% to 50% concentrate at room temperature.
● Soak the filter in a mild soapy detergent and leave for 5 minutes
6.6.3 Rinse: To remove any remaining substance and detergent.
● In a separate container with purified water remove the filter from detergent solution
and repeatedly dip into water to rinse until visibly clean from detergent residue.
● Let air dry before sanitizing.
6.6.4 Sanitize: To kill attached surviving bacteria and viruses that may still be present.
● In a spray bottle, make up the sanitizing solution by adding .25 - .5 ounces of product
per gallon of water dilution. (150-400 ppm active quat).
● Mist the filter lightly with the active quaternary ammonium compounds (QUATS)
solution.
● No potable water rinse is allowed.
6.6.5 Air Dry: To allow chemical sanitizers to evaporate and to prevent recontamination.
● Once air dry proceed to Sample and Validation Testing using SSOP-001
6.6.6 Monitoring/Corrective Action:Mustbe done after the systemis cleaned,sanitizedand
air-dried.
● Perform Visual Inspection of the equipment.
● Perform ATP Detection using methods defined in:
- SSOP-002: Using Dyes to perform microbiological testing
- SSOP-003: Optical lights can identify microbiological residues.
● If particulate matter is found on any area of the machine upon inspection, repeat the
clean-up procedure as detailed above for that particular area.
● Whenever there is residue remaining, you must log it in the cleaning log-book.
6.7 Cleaning and Sanitizing the Gaskets.
11. 6.7.1 Scraping/Pre-cleaning: Scrape and rinse to remove loose residue ahead of time.
● Remove all debris and physical matter using a fresh heavy duty wipe..
● Dispose the wipe and remove residue into the proper waste container.
6.7.2 Wash: Use detergent solutions to loosen and remove stuck-on substances.
● Prepare Oakite 33 detergent at 10% to 50% concentrate at room temperature.
● Soak the filter in a mild soapy detergent and leave for 5 minutes
6.7.3 Rinse: To remove any remaining substance and detergent.
● In a separate container with purified water remove the filter from detergent solution
and repeatedly dip into water to rinse until visibly clean from detergent residue.
● Let air dry before sanitizing.
6.7.4 Sanitize: To kill attached surviving bacteria and viruses that may still be present.
● In a cleanbucket,make upthe sanitizingsolutionbyadding1 - 2 ouncesof productper
4 gallons of water dilution. (150-400 ppm active quat).
● Dip or soak the gaskets in QUATs solution for 60 seconds.
● Remove gaskets from the QUATs solution and let air dry. No potable water rinse is
allowed.
6.7.5 Air Dry: To allow chemical sanitizers to evaporate and to prevent recontamination.
● Once air dry proceed to Sample and Validation Testing using SSOP-001
6.7.6 Monitoring/Corrective Action:Mustbe done after the systemis cleaned,sanitizedand
air-dried.
● Perform Visual Inspection of the equipment.
● Perform ATP Detection using methods defined in:
- SSOP-002: Using Dyes to perform microbiological testing
- SSOP-003: Optical lights can identify microbiological residues.
● If particulate matter is found on any area of the machine upon inspection, repeat the
clean-up procedure as detailed above for that particular area.
6.7.7 Whenever there is residue remaining, you must log it in the cleaning log-book.
6.8 Reassembling the Extraction System
12. 6.8.1 Locate collection chamber
● Place 10" gasket and place on the collection chamber
● Place the collectionchamberlidontop of the gasketsandwiching gasketbetweenthe
chamber and the lid.
● Secure lid to chamber by using a 10" double bolt clamp and tighten evenly.
● Place 2" gasket onto the 2" barrel of the collection chamber lid.
6.8.2 Place a 2" ball valve onto the 2" gasket.
● Secure ball valve to the lid with a 2" double bolt clamp and tighten evenly
● Place the 2" gasket on top of the ball valve.
6.8.3 Place the reducer,with2" side down onto the gasket and sandwichit betweenthe ball
valve.
● Secure the reducerto the ball valve to the lidwith a 2" double bolt clampand tighten
evenly.
6.8.4 Place a 3" gasket on either end of the material tube.
● Place 3"material tube lidontomaterial tube,sandwichinggasketbetweenlidandtube.
● Secure lid to the material tube with a 3" double bolt clamp and tighten evenly
● Run the extractorwithoutplanmaterial todistill andcleanthe butane that entersinto
the system without contaminating an extraction.
6.8.5 Place a 3" gasket onto the 3" side of the reducer.
● Place a 3" material tube onto the gasket.
● Secure material tube to the reducer with a 3" double bolt clamp and tighten evenly
● Secure the extractor to a stand or similar device.
6.8.6 Attach the auxiliary ball valve to the blue side of the manifold and tighten down the
fitting.
● Locate ¼" hose with 90 degree angle
● Attach the straight end of the hose to the blue side of the manifold and tighten the
fitting.
● Attach a hose to the centerport of the manifolddowntothe "T" on the recoverytank.
● This center line will serve as both a delivery and recovery line.
6.8.7 Take the 90 degree angle side of the hose attachedtothe blue manifoldandattachit to
the top of the material tube lid.
6.8.8 On the recovery tank the center tub is the "dip tube"
● The other 2 ports are the recovery ports.
● Attach one of the 2 6" hoses to the dip tube
● Attach the other 6" hose to one of the recovery ports.
● Join both hoses together with the 3 way "T"
● This is where the second "T" with the auxiliary ball valve is attached.
6.8.9 Attach the remaining hose to the red side of the manifold.
● Attach the other side of the "red" hose to the "out" of the heat exchanger.
13. 6.8.10 Attach a hose from the "in" of the heat exchanger to the "out" of the recovery pump.
6.8.11 Attach Filter dryer to the recovery pump.
● Remove red caps that hold the pressure washers in
● DO NOT LOSE the pressure washers.
● Center them correctly when placing them back into the filter dryer.
● Attach the 3/8" hose to the "in" of the filter dryer.
● Attach the otherendof the hose to the open 3/8" port on the collection chamber lid.
● Hook up the vacuum hose to the auxiliary ports on the recovery tank.
● Attach the other end of the hose to the vacuum pump.
6.8.12 EXTRACTOR IS NOW FULLY ASSEMBLED.
6.9 Testing for leaks
6.9.1 Use the SOP-011 for how to test for leaks using the BHO Extractor after assembly.
7.0 Records Maintenance
7.2 The record keeping requirements associated with this GPP requirement are found under
paragraphs 231(1)(a) and (2)(a),andparagraphs 231(1)(c) and (2)(b) of Part 11 of the Cannabis
Regulations.
License holders of the facility will ensure records will be maintained and demonstrate their
compliance with Part 5 of the GPP.
7.3 Records will be maintained for a minimum of 2 years unless required to hold further by law.
8.0 References
8.2 Cannabis Regulations and Act, Oct 2018
8.3 BHOGart Manufacturer manual
9.0 Revision History
Revision
Number
Section Description of Change Date
0 Initial Developed SSOP 15-2-2021
10.0 Authorization
Position / Title Signature / Name Date
14. Prepared By:
_______________
15-2-2021
Name
Approved By:
Responsible Person
Name
Quality Assurance Person
Name
Position / Title Signature / Name Date
Approved By:
Responsible Person
Quality Assurance Person
Learn more about SOP for Cannabis through the following Diploma and Certificate
programs
1. Certificate Program
Sanitation and Testing Requirements for Cannabis Production
Cannabis Sanitation Validation
2. Diploma Programs
Cannabis Quality Control and Quality Assurance
Industrial Cannabis Production Technology
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