Description of manufacturing process and process controls

1
Table of Contents

A EXTRACTION PROCESS ....................................................................................................................4

A.1 DETAILED DESCRIPTION OF THE PROCESS. ....................................................................................5

A.1.1 RECEIVING AND STORING CANNABIS FEEDSTOCK......................................................................................5

A.1.2. QUALIFICATION OF FEEDSTOCK .........................................................................................................5
A.1.3. MACERATION OF FEEDSTOCK ............................................................................................................5
A.1.4 EXTRACTING LIQUOR FROM MACERATION SOLUTION ................................................................................6
1.4.1 MAINTENANCE OF SCREW PRESS .........................................................................................................6
1.4.2 CLEANING STRATEGY .......................................................................................................................7
1.4.3 HEALTH AND SAFETY.......................................................................................................................7
A.1.5. FILTRATION OF LIQUOR ...................................................................................................................7
A.1.4. WINTERIZATION OF LIQUOR .............................................................................................................9
A.1.5 SOLVENT EVAPORATION ...................................................................................................................9
A.1.5.1. FUNDAMENTALS OF C-100 DISTILLATION ....................................................................................... 10
A.1.5.1 POWERING UP THE C-100........................................................................................................... 11
A.1.5.2. CONTROL PANEL....................................................................................................................... 12
A.1.5.2. PRIOR TO EQUIPMENT START UP ................................................................................................... 12
A.1.5.3. AUTO AND MANUAL MODES ........................................................................................................ 13
A.1.5.4. AUTOMATIC MODE SETTINGS ....................................................................................................... 13
A.1.5.2. PROCESS MONITORING............................................................................................................... 15
A.1.5.3. GENERAL ALARM PROTOCOL ....................................................................................................... 15
A.1.5.5. MAINTENANCE AND CLEANING .................................................................................................... 16
A.1.5.5.1 DAILY MAINTENANCE .............................................................................................................. 16
A.1.5.5.2 WEEKLY AND MONTHLY C-100 EQUIPMENT INSPECTION.................................................................. 17

B. QUALITY STANDARDS................................................................................................................... 17

B1 H EAVY METALS ............................................................................................................................... 17

B2 PESTICIDE RESIDUES......................................................................................................................... 18
B3 AFLATOXINS ................................................................................................................................... 19
B4. RADIOACTIVE CONTAMINATION ......................................................................................................... 19
B5 MICROBIAL CONTAMINANTS .............................................................................................................. 19
B6 MOISTURE CONTENT OF CANNABIS FLOWERS .......................................................................................... 20
B7. FOREIGN MATERIAL— MACROSCOPIC EXAMINATION................................................................................ 20
B8 RESIDUAL SOLVENTS ......................................................................................................................... 21
B9 VALIDATION METHODOLOGIES ............................................................................................................ 21

2
3
A Extraction Process
Table 1 below is a summary of the process

Table 1. Process summary with Quality Control Points

Step Activity QC points

Confirmation that it is cannabis.
Confirmation that the bulk
packaging is intact. No foreign
objects. 2 samples taken: 1
sample for handheld testing of
cannabinoid content to be
expressed in terms of dry mass.
One sampled preserved. Go/no
Biomass is received in bulk go decision on accepting the
containers and placed into shipment. Lot number created.
quarantine until it has been Recordkeeping begins. Material
1- Receiving inspected by QA entered into inventory.

Biomass is stored at room

temperature, 20-25 degrees C. Monitor temperature 2 x daily.
2. Storing RH <50% Visual inspection 1 x daily.
Ensures that biomass is
Biomass taken out of bulk completely submerged in
packaging and macerated in ethanol. Ethanol concentration
3. Maceration totes with 95% ethanol 2:1 w/w determined by gravimetric
1 Ethanol/biomass for 2 hours analysis

Biomass ran through Vincent

4. Pressing 1 press. Liquor collected Liquor is saved.
5. Maceration Biomass is macerated in 1/1 Ensures that biomass is
2. ethanol/biomass w/w for 1 hr saturated.
Biomass ran through Vincent
6. Pressing 2 press. Liquor collected Liquor is pooled with step 4.
Liquor is mixed with 5:1 ethanol
7. v/v and placed in -40 freezer Monitor temperature. Ensures
Winterization overnight that crystals form

4
 Waxes are saved for cosmetics
Decanting and flltration of market. Liquor is sent to
8. Filtration ethanol to remove waxes evaporator
Ethanol is evaporated in the C- Oil is dumped into totes to form
9. Evaporation 100 full spectrum oil.
Ethanol is tested for water
content and new ethanol is
10. Recycling addredd Gravimetric analyses
11. Bulk Full spectrum oil is placed in bulk
containers containers
Biomass is stored at room
temperature, 20-25 degrees C. Monitor temperature 2 x daily.
12. Storage RH <50% Visual inspection 1 x daily.

13. Shipping

A.1 Detailed description of the process.

A.1.1 Receiving and storing cannabis feedstock

A.1.2. Qualification of feedstock

The female inflorescences are either undivided or have disintegrated into their individual
parts. The closely spaced bracts and flowers of the whole inflorescence form a strongly
compressed panicle of about 1 to 5 cm length and width, with the dark green bracts
protruding somewhat. The light brown to brown styles and scarred branches are up to 1
cm long in total. The petals are green to light green and like the bracts are dense with
yellowish-white hairs and glued by resin. The decomposed drug has fragments of the
inflorescence stems, bracts and panicle sections as well as individual flowers and flower
organs. The single flower is approximately 5 to 10 mm long, sometimes short-stalked,
and consists of the hooded, green to light green petal, the 1 to 2 mm large whitish ovary,
which may contain a small brown ovule, and the brown stylus with 2 long, slender grain
branches. The fragments of the bracts are dark green to green, the inflorescence stems
light green. The bracts and all flower organs except the styles are more or less densely
covered with sticky glandular hairs due to secreted resin.

A.1.3. Maceration of feedstock

5
[1] At first start, use 50% ethanol at a ratio of 1: 2 kg EtOH/kg dry biomass to generate a
first stage liquor and a biomass cake.

[2] After 500 kg biomass has been processed, reuse the first stage liquor and biomass
cake for a second pass through the Vincent screw press.

[3] Collect the liquor and dispose of the cake as waste material.

[4] All maceration are to take 2 hours.

A.1.4 Extracting liquor from maceration solution

The extraction of cannabis liquor is performed with a KP-16 screwpress produced by

Vincent Corporation https://vincentcorp.com/

The KP16 Screw Press has a Variable Frequency Drive housed in an explosion proof box
located beside the press and attached via power cable to the press.

To turn on the machine, ensure the emergency stop button is in the “non -depressed”
position. Press the power button on the VFD box

Operation the KP16 involves three distinct functions.

1. Loading of material into the screw press hopper.
2. Collecting pressed liquor
3. Collecting the spent cake

Before the press is started, a container must be placed under the liquor collection flange
to collect the extracted liquor and a container must be placed under the end of the press
to collect the spent cake.

Prepare your mixture of biomass and ethanol in a loading container. Elevate the container
to the hopper and load the mixture into the press at a rate that does not overflow the press
hopper.

The press’s running variables are rpm speed of the screw and psi of the pressure cone.
The operator can adjust both speed and pressure to achieve the desired level of moisture
extraction from the mixture. This is determined through evaluation of the spent cake.

The spent liquor can be remixed with new material to ach ieve a higher concentration of
pressed liquor and likewise the spent cake can be remixed and pressed a second time to
ensure a more thorough extraction.

1.4.1 Maintenance of screw press

At the end of each work day and prior to the start of each day an operator will do a visual
inspection of the screw press. This includes the following:

6
 a) The hopper
b) The pressure cone
c) The screens and the liquor flange
d) The motor and the electrical connections
e) The screw press platform
f) The air pressure hoses and connection points
The manufacturer recommends that every six months the screens should be removed
and inspected. The Screens are replaced if the screens’ integrity is compromised.

1.4.2 Cleaning Strategy

A cleaning of the press is scheduled between each Batch of material. The machine is
visually inspected, and any lodged material is dislodged with a high -pressure air hose.
Following that, the press is rinsed twice with water containing 10% ethanol and followed
by visual inspection to confirm the absence of particulate material or resinous residues.
If visual inspection detects the presence of such residues, the cleaning sequence is
repeated.

1.4.3 Health And Safety

All operators using the KP16 and working with exposure to ethanol is clothed
appropriately. This includes safety goggles, ethanol resistant gloves, boots and aprons.
A respirator is made available for use should fumes from the ethanol be exposed to the
operators. At no time should any operator put his or her hands inside the KP16’s hopper
while the press is running. The KP16 has an emergency stop button. All operators are
acquainted with the location and operation of the emergency stop button.

Ethanol fumes are a concern and the room is specially ventilated to circulate in fresh ai r
at a higher frequency. The screw press is located in an explosion proof room for the
safety of all those within the greater facility. A water hose is available to the operators
should ethanol get on their skin

A.1.5. Filtration of liquor

The filtration of the liquor is a three step in-line process that occurs between the KP16 screw
press and the first storage tank. The in-line filters are made of stainless steel by the Arbor
Fabricating company. http://arborfab.com/Inline-Filters_c_39.html
The following diagram illustrates the process.

7
Stage 1: The liquor from the Press is funneled and collected into a 1000L transfer tote. It passes
through a 100 micron filter that is designed to fit inside the opening of the large tote.

Stage 2: The liquor is then pumped from the bottom of the tote using the Lutz B200 air motor
through a 2 inch hose into a holding tank. During its transit the liquor passes through a 12 inch
long x 6 inch wide cartridge which houses a 15 micron stainless steel filter.

Stage 3: A second 12 inch long cartridge is connected to the 2 inch house downstream from the
first one. This cartridge is 2 inches wide and houses a 5 micron stainless steel filter. Once the
liquor passes through this final filter it is deposited in a holding tank.

Spare filters and filter cartridges have been purchased for quick swap-out when filter cleaning is
necessary. Cleaning intervals are undetermined at this time but will be required when flow rate
is noticeably attenuated.

Filter Cleaning can be a combination of water immersion and/or medium pressure water spray.

Below are the individual products purchased from Arbor Fabricating.

1310/5/Viton 12" Inline Sanitary Filter Cartridge -$141.50 x 2 $283.00

Cartridge Size: 2"
Filter mesh size: 5 micron backed with 800 micron
Kind of gasket: Viton

8
 1310/15/Viton 12" Inline Sanitary Filter Cartridge -$153.50 x 2 $307.00
Cartridge Size: 6"
Filter mesh size: 15 micron
Kind of gasket: Viton

1300/5/1inchhb/viton 2" TC x 12" Inline Sanitary Filter$269.50 x 1 $269.50

Assembly -
What size mesh would you like?: 5 micron backed
with 800
What size hose barb1" hose barbs
type of gaskets would you like?: Viton

137/15/hb1/viton /pbwn 6" TC x 12" Inline Sanitary$599.50 x 1 $599.50

Filter Assembly - PATENT PENDING
micron size: 15 micron
TC Connection Size: 2" TC Connection
Kind of gasket: Viton

3500/100m Tote Filter$125.00 x 3 $375.00

Filter size micron: 100

A.1.4. Winterization of liquor

[1] Crude cannabis oil from cold pressing using the Vincent screw press is dissolved 1:4
v/v in 95% ethanol and mixed thoroughly.

[2] After 2 hours incubation at –80o C the ethanol/cannabis oil mixture is filtered in vacuo
with a Whatman No 2 filter paper to remove 90% of the lipids. The precipitate is stored
as wax and labelled according to original lot number.

[3] The filtrate is then let to sediment for another 2 hours and filtered with a Whatman No
1 filter paper in vacuo. The precipitate is stored as wax and labelled according to original
lot number.

[4] The waxes are deemed to be waste material for the time being.

A.1.5 Solvent evaporation

[The ethanol is then removed from the filtrate in vacuo using the C-100 evaporator (see
C-100),until the oil becomes milky or it has been exposed to 70 o C for one hour and more
and no additional evaporates emerges; This material is now labelled “Winterized full
spectrum oil” and receives a lot number of the original cannabis material. Alphabetical

9
suffix (e.g. A or more is added to the lot number to mark different days of operation to
increase traceability.

Evaporation of the winterized liquor is performed with a C-100 produced by Maratek

Environmental (https://www.maratek.com/) as follows:

A thorough visual walkaround inspection of the equipment and surrounding area must be
performed prior to starting-up of the C-100 Equipment.

It is imperative that a safe and clean environment be prepared and maintained around
the C-100. Visually inspect all surfaces of the C-100 Equipment for leakages, and or signs
of overflow, or overheating.

Ensure all external water and air connections are in place, and that both water and air
pressure are at the specified pressure.

Nominal Values are:

1. Air pressure set to 85 psi, plus-minus 5 psi;

2. Water pressure set to 50 cfm, plus-minus 5 cfm.

Ensure that all electrical disconnects are in the ON position.

Ensure that the Chiller is ON and that the coolant connection valves are in the open
position. Ensure chiller pumps are on, and operational.

Ensure via sight glass on the C-100 that oil and coolant levels are readable and
maintained.

A.1.5.1. Fundamentals Of C-100 Distillation

All solvents have specific and described boiling points; as well, all flammable solvents
have specific auto-ignition temperatures.

To prevent auto-ignition, the maximum surface temperature when the C-100 is phase
functioning (AUTO MODE ) should never be higher than the auto-ignition temperature of
the solvent being distilled. NOT ADHERING TO THIS PRINCIPLE MAY RESULT IN FIRE
AND OR EXPLOSION.

Ethanol has a distillation of 78o C, a flashpoint temperature of 13 o C, and an autoignition

temperature of 363o C. The boiling point of a liquid is the temperature at which the liquid
is transformed from a liquid state into a gaseous state at atmospheric pressure (101 kPa).
In certain cases, it is common practice to set the temperature of the heating medium 30
to 40o C, higher than the boiling point of the solvent. (to allow for the distillation of the
solvent to be performed) The C-100 is designed for the reuse of flammable and non-
flammable solvents having boiling points of up to 180 o C.

10
The unit separates the cannabinoid enriched oil from the solvent, which once recycled
may be immediately directed for reuse. The distillation process will not alter the
characteristics of the solvent. The enriched oil remains at the bottom of the vessel and
can be easily collected for further processing.

The heat settings, along with the time, vacuum criteria, and cool-down period must be
designated with the entire process taken into account. (An example of said parameters is
defined later in this document). Produ ction may be augmented by setting the heating
medium temperature at higher than prescribed levels. This can lead to foaming of the
product, and eventual damage to the equipment.

The criteria governing the parameters set forth for the C-100 program are based on
scientific data acquired during in -process testing; such as specific gravity, density, and
ethanol-cannabis maceration ratio; (proprietary to Instadose Pharma Corp). Testing of
the RAW Ethanol-Cannabinoid infused mixture shall be performed, by qualified IDP
personnel only, and shall govern changes to the program criteria as the RAW test results
dictate.

The heat of vaporization is an indication of the speed of the evaporation process and
hence of the hourly rate of production of the equipment. The heat of vaporization is the
amount of energy required to transform 1 kilogram of solvent from its liquid state into its
gaseous state. It is expressed as kcal, per kilogram. NOTE: The distillation rate of any
solvent is not the function of the temperature, but rather, the heat of vaporization. Thusly,
the higher the heat of vaporization, the lower the rate of distillation time.

The density of a liquid is the weight in kilograms of one liter of material. It is expressed as
kilograms per decimeter. Therefore, 1 liter, equals 1 cubic decimeter. The higher the
difference in densities of the products, the faster and easier is the separation process.

IN ALL CASES, THE OPERATOR MUST ALLOW THE PRODUCTION CYCLE OF THE
EQUIPMENT TO OPERATE AS THE PROGRAM DICTATES.

DO NOT ATTEMPT TO MAKE CHANGES WITHOUT IDP AUTHORIZED MANAGERIAL

PERSONNEL BEING PRESENT.

A.1.5.1 Powering up the C-100

PRIOR TO TURNING ELECTRICAL POWER ON, ENSURE THE

FOLLOWING
All covers, lids, and doors are closed, and secure
All ball gate valves are in the correct position
All switches are in the OFF position
Verify power and ground connections, and that purge has been completed for the
electrical junction box, check purge alarm box (located top right of the control panel
box)

11
 When the above list has been
completed you may turn the
power ON to the C-100

A.1.5.2. Control panel

All functions except for the

EMERGENCY STOP SWITCH, are
entered through the color touch
monitor of the Allen Bradley 15-inch
screen with PLC Compact Logic
L33ER. Whether in AUTO or
MANUAL MODE it is advisable to
touch the screen with clean hands
only, and never with a sharp object.

The main variables pertaining to

distillation are the type of solvent,
time, temperature and pressure. The
nominals of these parameters are
determined by numerous factors that
are inherent to the ethanol infused biomass mixture. Therefore, the set-up of the
automated program which determines said parameters shall be performed by IDP
authorized personnel and-or their delegates only.

A.1.5.2. Prior to equipment start up

Ensure that 2 totes of Raw Ethanol Cannabinoid Mixture are by the feed valves of the C-
100, (left-hand side of the unit when looking face on to the collection bay of the C -100)
and that the vacuum feed lines are placed into the individual totes. Ensure the LLST Float
Switch Wand is inserted and orientated in the correct position of each individual tote.

Ensure to place a clean and visually inspected tote at the base of the collection bay of
the C-100 where the discharge valve and handle are. (See Fig No. 1) Ensure to place an
HLST Float Switch Wand into the tote. The collection of ethanol distilled raw oil shall be
performed here. The operator must ensure to keep the area clean, tidy and sanitary.

Go to the Auto Screen of the Allan Bradley Controller, and ensure the program is in AUTO
mode

A program cycle can consist of 5 distinct phases, plus a cool-down phase. Each phase
save for the cool-down phase may be selectively chosen to be enabled ON or OFF.

12
At the start of the cycle, the PLC looks at phase 1, verifies that the phase was selected
to be either ON or OFF. When the phase is selected ON, the PLC will proceed to perform
the functions selected (criteria being temperature, time, pressure ) in that phase. Once
an ON phase is completed, the PLC moves on the next sequential phase that has been
enabled ON.

When a phase is selected OFF, then the PLC will move to the next sequential phase
selected ON.

After having gone through all the ON selected phases, (maximum 5), the PLC will perform
the functions dictated by the cool-down phase.

Ensure that the settings of each applicable Phase are entered, correct, and Enabled
Press the START Button of Phase 1

The distillation system is autonomous and runs based on the pre-established parameters
of the program. No technician is to alter the pre-programmed settings without expressed
and written authority of IDP managerial staff.

A.1.5.3. Auto and manual modes

The C-100 has the capability to operate in both AUTO and MANUAL modes. If one were
to assume all pertinent scientific data of the Raw ethanol-cannabinoid mixture was
constant, then it would be possible to establish a single set of parameters that would be
utilized in the set-up of the program for the distillation of the ethanol from the cannabinoid-
infused raw oil. The following is a list of parameters that would represent an ethanol
distillation from the Raw oil based upon average known data. During actual processing,
the data acquired from in-process testing of the macerated ethanol cannabis mixture will
dictate specific parameters to be used in the C-100 autonomous program set-up.

A.1.5.4. Automatic mode settings

INPUT PARAMETERS for SET -UP SCREEN

On the settings screen of the HMI, input the following parameters:

Step 1:

Step 2: volume

Step 3: Step 4: Step 5: Step 6: Step 7:

Set Fill Watchdog to 90 minutes

13
Set Working Level Setpoint to 24 inches ( Adjust this parameter to change the in the
distillation vessel )

Set High-Level Alarm Setpoint to 30 inches

Set Solvent Delay to 3 minutes
Set Solvent Watchdog to 5 minutes
Set THB ( temp of product inside the vessel ) Setpoint to 110 degrees F

Set the Emergency Pump Setpoint to 180 degrees F

Phase 1 Settings: Fill

Set the parameters highlighted on the screen as follows:

Phase Enable..............Phase Time......................1 minute AEP Disabled..............AEP

SP( F ).................200 degrees Heat Enabled..............THC SP( F )......................240
degrees Fill Enabled................THS Fill SP ( F )...............125 degrees Low Vacuum
Enabled.....Vacuum SP (in Hg)...........-20 inches High Vacuum Disabled

Scraper Enabled

Phase 2 Settings: Auto Top-Up

Set the parameters highlighted on the screen as follows:

Phase Enabled..............Phase Time..............600 minutes AEP Disabled................AEP

SP ( F )................200 degrees Heat Enabled................THC SP ( F )................240
degrees Fill Enabled...................THS SP ( F )................125 degrees Low Vacuum
Enabled.......SP ( in Hg )..................-20 inches High Vacuum Disabled

Scraper Enabled

Phase 3 Settings: Boil Down

Set the parameters highlighted on the screen as follows:

Phase Enabled.............Phase

Time..............480 minutes AEP Enabled................AEP SP ( F )...................88 degrees

Heat Enabled...............THC SP ( F )..................240 degrees Fill Disabled.................THS
Fill SP ( F )............180 degrees Low Vacuum Enabled....Vacuum SP ( in Hg )......-20
inches High Vacuum Disabled

Scraper Enabled

Phase 4 Settings; Decarboxylation

14
Set the parameters highlighted on the screen as follows:

Phase Enabled.............Phase Time................180 minutes AEP Enabled...............AEP

SP ( F )....................88 degrees Heat Enabled...............THC SP ( F ).......260 to 280
degrees Fill Disabled................THS SP ( F )....................180 degrees Low Vacuum
Enabled....Vacuum SP ( in Hg ).......-20 inches High Vacuum Disabled

Scraper Enabled

Phase Cool Down

Set the parameters highlighted on the screen as follows

Phase Enabled..............Phase Time.................60 minutes AEP Disabled...............AEP

SP .........................1 degree Heat Disabled...............THC SP............................1 degree

A.1.5.2. Process monitoring

Check that the unit is filling from the tote properly ( visual )
Check that the proper vacuum has been achieved ( gauges on panel, and HMI
screen )
Check Temperatures ( on-screen and equipment )
Check for any Alarms ( on-screen )
Check liquid levels in all pertinent feed and collection totes ( visual )

A.1.5.3. General Alarm Protocol

The alarm protocol runs continuously in the background. It operates regardless of whether
a cycle is in auto or manual mode. There are three basic types of alarms; and
corresponding actions are taken when an alarm is detected by the PLC; namely a General
Fault, a Specific Fault, or a Non -Fatal Fault.

1. General Fault: When this type of fault is detected, all outputs, except the cooling
system is disabled. The LCD will display the appropriate fault message until the specific
problem is dealt with and disappears.

2. Specific Fault: When this type of fault is detected, only the corresponding specific
output is disabled. The LCD will display the appropriate fault message until the specific
problem is dealt with and disappears.

3. Non-Fatal Fault; When this type of fault is detected, no outputs are disabled. The LCD
will display the appropriate fault until the specific alarm problem is dealt with and
disappears. See Figure 2

In AUTO program mode the C-100 will stop after the final Phase has been run, and the
Cool-Down phase is completed.

15
Figure 2

Whenever this switch is activated, all functions (except for the cooling system are
stopped. The outputs are released only once the switch has been replaced to its normal
operating mode, and there are no other alarms triggered. The Button is for emergency
situations only. Once the switch has been de-activated the operator must start again from
the start-up screen to resume.

A.1.5.5. Maintenance and cleaning

The equipment is designed to be self-cleaning on the inside of the distillation vessel.

However, the exterior of the vessel housing, and all plumbing, hydraulic, and pneumatic
lines, fixtures and manifolds must be kept clean and sanitary. The Exterior stainless steel
walls of the equipment and all other equipment surfaces are to be cleaned using warm
water and soap.

The C-100 is equipped with a dual-purpose SCRAPER SYSTEM. This allows for the
continuous blending of the solvent-cannabinoid mixture during distillation. As well the
scraper in conjunction with the sprayer maintains the inner walls of the vessel clean and
free from residual contaminants. The built-in scraper operation is a programmed option
of the distillation cycles.

Maintenance of the C-100 Equipment is to be performed only by trained IDP

personnel

A.1.5.5.1 Daily Maintenance

Aside from the daily maintenance that the C-100 autonomously performs via the internal
scraper program to ensure the cleanliness of the inner wall of the distillation vessel.

16
Inspect and clean Fill Strainer. Open the strainer cover and verify that the strainer is clean.
When replacing the strainer cover ensure the strainer cover O RING is in place, to ensure
the proper seal of the strainer assembly.

Visually inspect and clean (if necessary) all floats pertaining to the distillation chamber.
All floats must be free of grime and residues, and free moving on their individual and
respective wands. Ensure; ( if the float is removed for cleaning ), that it is returned on the
wand to the same orientation from which it was removed.

Purge all water from compressed air coalescing filters. Compressed air utilized by the C-
100 equipment must always be clean and dry.

A.1.5.5.2 Weekly And Monthly C-100 Equipment Inspection

Check the oil Level in the oil expansion housing when the unit is cool. If required top-up
the reservoir with the specified type of oil. Do Not Overfill. Inspect weekly.

Drain the fluid from the re-circulation tank and replace it with fresh 80 %: 20% water-glycol
mixture. Inspect weekly and change monthly at a minimum.

Ensure the path between the vapor tube inside the distillation chamber, and the vacuum
tank is clean and free from dirt or residue. Ensure the gaskets of the sanitary clamps are
in good condition prior to re-assembling. Clean ethanol is used for this type of cleaning
process. Inspect weekly.

A.1.5.5.2 Yearly Maintenance Or Every 2000 Working Hours

Yearly or every 2000 hours of operation the thermal oil must be changed. This operation
must be performed when the C-100 unit is cold.

Thermal oil must be of the following specification: A cracking temperature of higher than
320 degrees C with a viscosity of approximately 31 cSt at 40 degrees C, and 53 cSt at
100 degrees C. Commonly used brands are Calfo - AF, Mobiltherm 605, Essotherm 500,
Shell Thermia B, Total Seriola 2100

During usage of the C-100 equipment, carbon deposits tend to form on the electrical
heating elements. For proper heat exchange, the heating elements must also be removed
and cleaned every year. This procedure is to be performed at the same time the thermal
oil is changed. All C-100 maintenance procedures must be performed by IDP Managerial
Personnel or their delegate.

B. Quality standards

B1 Heavy metals

17
Heavy metal contaminant thresholds are from Guideline on quality of herbal medicinal products
traditional herbal medicinal products. (https://www.canada.ca/en/health-
canada/services/drugs-health-products/natural-non-prescription/legislation-
guidelines/guidance-documents/quality-guide.html)

and determined as <0.30 PPM for arsenic, < 0.20 PPM for cadmium, < 0.7 PPM for lead, and < 0.7
PPM for total mercury.

B2 Pesticide residues

Full screening of pesticides excluding the following list of pesticides which as of August 9, 2018,
there are 22 registered pesticides approved by PMRA for use on cannabis (marijuana) that is
produced commercially indoors. They are:
Agrotek Ascend Vaporized Sulphur
Bio-Ceres G WP
Bioprotec Caf
Bioprotec Plus
Botanigard 22 WP
Botanigard ES
BW240 WP Biological Fungicide
Cyclone
Doktor Doom Formula 420 Professional Use 3-in-1
Influence LC
Kopa Insecticidal Soap
Lacto-San
MilStop Foliar Fungicide
Neudosan Commercial
Opal Insecticidal Soap
Prestop

18
 Purespray green spray oil 13E
Rootshield(R) WP Biological Fungicide
Rootshield HC Biological Fungicide Wettable Powder
Rootshield Plus WP Biological Fungicide
Sirocco
Vegol Crop Oil

Guidance is provided by Health Canada’s mandatory testing requirements

https://www.canada.ca/en/public-health/services/publications/drugs-health-
products/cannabis-testing-pesticide-requirements.html dated November 8, 2018.

For examples:
• hexachlorocyclohexane (HCH) or benzene hexachloride (BHC), lindane, methoxychlor •
chlorinated phenoxyalkanoic acid herbicides: 2,4-D, 2,4,5-T • organophosphorus pesticides:
carbophenothion (carbofenotion), chlorpyrifos and methylchlorpyrifos, coumaphos (coumafos),
demeton, dichlorvos, dimethoate, ethion, fenchlorphos (fenclofos), malathion, methyl
parathion, parathion • carbamate insecticides: carbaryl (carbaril) • carbamoyl benzimidazoles:
benomyl, carbendazim • dithiocarbamate fungicides: ferbam, maneb, nabam, thiram, zineb,
ziram • amino acid herbicides: glyphosate • inorganic pesticides: aluminium phosphide, calcium
arsenate • miscellaneous: bromopropylate, chloropicrin, ethylene dibromide, ethylene oxide,
methyl bromide, sulfur dioxide • pesticides of plant origin: tobacco leaf extract, pyrethrum fl
ower, and pyrethrum extract; derris and Lonchocarpus root and rotenoids.

B3 Aflatoxins

< 20 µg/kg (ppb) for aflatoxins (B1+B2+G1+G2)

<5 µg/kg (ppb) for aflatoxin B1

Eur. P. 2.8.18 standards

B4. Radioactive contamination

For material produced outside Canada for sale anywhere in the world, tests for ionizing radiation
will conducted to assess the presence of radioactivity at <600 Becquerels/kg of cannabis flowers.
If radioactivity is detected, further analyses will be conducted to determine the nature of the
radioactive elements.

B5 Microbial contaminants

Method Specified reference value

Test Item

19
 1.0 Total Aerobic Ph. Eur. 2.6.12 ≤ 10,000 cfu/g
microbial count (TAMC)

2.0 Total Yeast & Molds Ph. Eur. 2.6.12 ≤ 100 cfu/g
count (TYMC)

3.0 E. coli Ph. Eur. 2.6.31 absent /g

4.0 Salmonella spp. Ph. Eur. 2.6.31 absent /25 g

5.0 Bile tolerant Gram- Ph. Eur. 2.6.31 ≤ 100 cfu/g

Negative Bacteria

6.0 Ph. Eur. 2.8.18 < 2.0 ppb

Aflatoxin B1

7.0 Aflatoxin B2 Ph. Eur. 2.8.18 < 2.0 ppb

8.0 Aflatoxin G1 Ph. Eur. 2.8.18 < 2.0 ppb

9.0 Aflatoxin G2 Ph. Eur. 2.8.18 < 2.0 ppb

https://www.medicinalgenomics.com/wp-
content/uploads/2013/04/CFU_Tolerance_European.pdf

B6 Moisture content of cannabis flowers

The specification for moisture content for dry cannabis is 6-15%.

B7. Foreign material—macroscopic examination

Each lot of dried cannabis marihuana product is to be visually inspected for macroscopic
contaminants:

Glass: none
Stems: limit 50 cm/kg
Seeds: limit 100 mature seeds/kg--some strains tend to produce immature seeds
spontaneously.
Insects: none
Visual moulds: None

20
B8 Residual solvents

No more that 5000 ppm residual class 3 solvents is permissible in cannabis oil.

B9 Validation methodologies

All tests must be conducted using validated methodologies which are kept as permanent records
and re-certified by QA annually.

All test results are an integral part of the Master Lot Documentation for each lot.

No lot is released by QA unless until reviewing the tests and finding results within acceptable
thresholds.

Non-compliance to test results may result in an investigation as to cause and re-analyses 3 times
before a non-compliant lot is rejected.

B10 Chemical analyses

Specified reference
Test Item Method
value
1.0 loss of drying Ph. Eur., current max. 10 %
edition, 2.2.32
2.0 Cannabinol Test according DAB max. 1,0 %
2018, Cannabis flos,
method 2.2.29
3.0 Assay Test according DAB not less than 90,0 %
tetrahydrocannabinol 2018, Cannabis flos, and not more than
(THC) method 2.2.29 110,0 % of the
strength declared
4.0 Assay cannabidiol Test according DAB not less than 90,0 %
(CBD) 2018, Cannabis flos, and not more than
method 2.2.29 110,0 % of the
strength declared

5.0 Heavy Metal As Ph. Eur. 2.4.27 <3.0 ppm

(Arsenic)

21
10.0 Heavy Metal Cd Ph. Eur. 2.4.27 <0.5 ppm
(Cadmium)

22