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Viper Self-contained E-Liquid Compounding System Overview

The First FDA compliant fully automated, self-contained e-liquid compounding system. System Operational Description The production system is integrated with a flexible batch management system that provides a platform for automatic control and electronic record-keeping to comply with FDA regulations 21 CFR 210, 211, and 11. Proven products from Rockwell Automation provides the core of control and information management system.  It provides the authorized operator with a secure tool for designing flexible recipes that combine operator-entered and automatic data collection into a single work flow.  In-process weights are collected automatically and used to manage the flow of ingredients and finished products between storage and blending vessels. System components, including motors and automatic valves are sequenced according to the recipes’ logic.  Data are stored in a relational database management system for long-term storage and reporting.  PS&D supports the information technologies associated with the recipe management and data collection processes through secure cloud-based computing and network communications platforms.

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VIPER
THE FIRST FDA COMPLIANT
FULLY AUTOMATED SELF-CONTAINED
E-LIQUID COMPOUNDING SYSTEM
Process, Systems & Design
Westminster, Maryland
410-861-6437
Info@processsystems and
design
http://processsystemsdesign.co
WHY VIPER?
• AFFORDABLE AT <$100K
• UNIT FITS INTO A 6’X6’X3’ ENVELOPE IF NEEDED
• LOW USE AND OCCUPANCY COSTS (FLOOR SPACE)
• COMPLIANT – PHARMA GRADE HARDWARE & SOFTWARE
• ENSURES THAT ANY EMERGING FDA REGULATIONS WILL BE MET
• CLOUD-BASED AUTOMATED RECORD KEEPING/REPORTING
• AUTOMATED SYSTEM CLEANING CAPTURES REFUSE FOR DISPOSAL
• SAFE – NO EXPOSURE TO HAZARDOUS CHEMICALS
• ADAPTABLE
• VIPER IS DESIGNED TO FIT INTO A WIDE RANGE OF BUSINESS MODELS
• WORKS EQUALLY WELL IN OR OUT OF CLEAN ROOM ENVIRONMENTS
• ONE VIPER UNIT MAKES 20L TO 200L BATCHES & LARGER
• USES YOUR EXISTING PACKAGING AND LABELING OR EQUIPMENT OR OURS
• QUICK CHANGEOVER OR PARALLEL LINES ACCOMMODATE A WIDE RANGE OF FLAVORS
• SCALABLE
• ADDING UNITS WILL ACCOMMODATE SIMULTANEOUS BATCHES/SKU’S
• ALLOWS FOR INCREMENTAL THROUGHPUT INCREASES AND MORE FLAVORS
• MULTIPLE VIPER UNITS CAN RUN CONCURRENT IN THE SAME SOFTWARE ENVIRONMENT
• ENABLES JUST-IN-TIME MFG. TO REDUCE SPOILAGE AND STORAGE COSTS
POSSIBILITIES
Your Ingredients & Your Brand
Our System
Single Line - Batches at 20L to 200L
N% & Flavors run in serialized batches
Quick clean and change
Pharma-grade
MES
 Batch Records & Statistics
 Electronic Work Instructions
 QA & Compliance Reports
(FDA)
 Cost & Throughput Analysis’
VIPER
MORE POSSIBILITIES
Your Ingredients & Your Brand
Our SystemParallel Lines Using Shared Assets
Multiple SKU’s Running Simultaneously
Unlimited Expandability
Flexible ml Output - Wholesale or Retail
Pharma-grade
MES
 Proprietary Formulae
 Batch Records & Statistics
 Electronic Work Instructions
 QA & Compliance Reports
(FDA)
 Cost & Throughput Analysis’
VIPER
VIPER
VIPER
30 ml or larger
Available in 3 standard sizes
• VIPER I -Small Scale- < 20 liters
• VIPER II -Mid Scale >20 L < 200 L
• VIPER III -Large Scale > 200 L Sized as required
Typical Specification for Mid-Size Unit
• The unit will be constructed in a welded skidded frame form factor
(Type 304) for all non-product contact surfaces with piping, valves,
pumps, regulators etc. to be a minimum 3A Sanitary 316L Stainless
Steel construction.
Unit to be FULLY enclosed with Positive HEPA filtration to meet Class
10,000
• Overall Dimensions approx. 72" l x 72" h x 32" d
• This unit will utilize high grade 3A sanitary equipment which is
currently commercially available and suited for this design
• Pump(s) will be of the positive displacement full sanitary TRI CLAMP
construction capable of supplying a min of 5 GPM of Glycerin @ 70
Deg F (drum heater as an option to increase flow characteristics)
• All valves shall be 3A Sanitary tri-clamp - Automatic valves are
pneumatically actuated
VIPER SPECIFICATIONS
VIPER SPECIFICATIONS
Capacities
 Fully mixed batches 20-150 L/ Batch
 PG and Glycerin supply from 55 gal drums housed in the unit
 Concentrate flavor of 1-20 L
 Pure Nicotine (99%) 1 Liter- 30 Liter Drum
CIP
 CIP Solution concentrate 5 gal (Alconox or similar)- mixed with city water to
obtain desired concentration-utilizing educator technology
Requirements
 City Water > 40 psi
 Compressed Air Min 80 psi 100 cfm required for Actuators and AIR PURGE Phase
 Electrical 208 VAC 3 phase (120V and other power available on request)
Label Printer-2.75" x 1.25" Thermal transfer Paper Label

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Viper Self-contained E-Liquid Compounding System Overview

  • 1. VIPER THE FIRST FDA COMPLIANT FULLY AUTOMATED SELF-CONTAINED E-LIQUID COMPOUNDING SYSTEM Process, Systems & Design Westminster, Maryland 410-861-6437 Info@processsystems and design http://processsystemsdesign.co
  • 2. WHY VIPER? • AFFORDABLE AT <$100K • UNIT FITS INTO A 6’X6’X3’ ENVELOPE IF NEEDED • LOW USE AND OCCUPANCY COSTS (FLOOR SPACE) • COMPLIANT – PHARMA GRADE HARDWARE & SOFTWARE • ENSURES THAT ANY EMERGING FDA REGULATIONS WILL BE MET • CLOUD-BASED AUTOMATED RECORD KEEPING/REPORTING • AUTOMATED SYSTEM CLEANING CAPTURES REFUSE FOR DISPOSAL • SAFE – NO EXPOSURE TO HAZARDOUS CHEMICALS • ADAPTABLE • VIPER IS DESIGNED TO FIT INTO A WIDE RANGE OF BUSINESS MODELS • WORKS EQUALLY WELL IN OR OUT OF CLEAN ROOM ENVIRONMENTS • ONE VIPER UNIT MAKES 20L TO 200L BATCHES & LARGER • USES YOUR EXISTING PACKAGING AND LABELING OR EQUIPMENT OR OURS • QUICK CHANGEOVER OR PARALLEL LINES ACCOMMODATE A WIDE RANGE OF FLAVORS • SCALABLE • ADDING UNITS WILL ACCOMMODATE SIMULTANEOUS BATCHES/SKU’S • ALLOWS FOR INCREMENTAL THROUGHPUT INCREASES AND MORE FLAVORS • MULTIPLE VIPER UNITS CAN RUN CONCURRENT IN THE SAME SOFTWARE ENVIRONMENT • ENABLES JUST-IN-TIME MFG. TO REDUCE SPOILAGE AND STORAGE COSTS
  • 3. POSSIBILITIES Your Ingredients & Your Brand Our System Single Line - Batches at 20L to 200L N% & Flavors run in serialized batches Quick clean and change Pharma-grade MES  Batch Records & Statistics  Electronic Work Instructions  QA & Compliance Reports (FDA)  Cost & Throughput Analysis’ VIPER
  • 4. MORE POSSIBILITIES Your Ingredients & Your Brand Our SystemParallel Lines Using Shared Assets Multiple SKU’s Running Simultaneously Unlimited Expandability Flexible ml Output - Wholesale or Retail Pharma-grade MES  Proprietary Formulae  Batch Records & Statistics  Electronic Work Instructions  QA & Compliance Reports (FDA)  Cost & Throughput Analysis’ VIPER VIPER VIPER 30 ml or larger
  • 5. Available in 3 standard sizes • VIPER I -Small Scale- < 20 liters • VIPER II -Mid Scale >20 L < 200 L • VIPER III -Large Scale > 200 L Sized as required Typical Specification for Mid-Size Unit • The unit will be constructed in a welded skidded frame form factor (Type 304) for all non-product contact surfaces with piping, valves, pumps, regulators etc. to be a minimum 3A Sanitary 316L Stainless Steel construction. Unit to be FULLY enclosed with Positive HEPA filtration to meet Class 10,000 • Overall Dimensions approx. 72" l x 72" h x 32" d • This unit will utilize high grade 3A sanitary equipment which is currently commercially available and suited for this design • Pump(s) will be of the positive displacement full sanitary TRI CLAMP construction capable of supplying a min of 5 GPM of Glycerin @ 70 Deg F (drum heater as an option to increase flow characteristics) • All valves shall be 3A Sanitary tri-clamp - Automatic valves are pneumatically actuated VIPER SPECIFICATIONS
  • 6. VIPER SPECIFICATIONS Capacities  Fully mixed batches 20-150 L/ Batch  PG and Glycerin supply from 55 gal drums housed in the unit  Concentrate flavor of 1-20 L  Pure Nicotine (99%) 1 Liter- 30 Liter Drum CIP  CIP Solution concentrate 5 gal (Alconox or similar)- mixed with city water to obtain desired concentration-utilizing educator technology Requirements  City Water > 40 psi  Compressed Air Min 80 psi 100 cfm required for Actuators and AIR PURGE Phase  Electrical 208 VAC 3 phase (120V and other power available on request) Label Printer-2.75" x 1.25" Thermal transfer Paper Label
  • 7. VIPER SPECIFICATIONS System Operational Description The production system is integrated with a flexible batch management system that provides a platform for automatic control and electronic record-keeping to comply with FDA regulations 21 CFR 210, 211, and 11. Proven products from Rockwell Automation provides the core of control and information management system. It provides the authorized operator with a secure tool for designing flexible recipes that combine operator-entered and automatic data collection into a single work flow. In- process weights are collected automatically and used to manage the flow of ingredients and finished products between storage and blending vessels. System components, including motors and automatic valves are sequenced according to the recipes’ logic. Data are stored in a relational database management system for long- term storage and reporting. PS&D supports the information technologies associated with the recipe management and data collection processes through secure cloud- based computing and network communications platforms.
  • 8. BASIC BUSINESS TERMS • PS&D Engineering will work with you to implement our equipment into your existing environment • Due to emerging demand we are taking small deposits to reserve a schedule position • Current lead time is 90 days • Bottling units can be purchased/integrated as part of the system or acquired separately • MES software suite can be purchased separately and adapted to existing systems • PS&D will provide system operation training as part of the system purchase price • We will provide additional support for system set-up/launch. Customer covers travel costs and expenses • If client has existing clean room then clean box can be removed for simplicity and cost reduction