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Blister Packaging System

SMB Group has significant experience validating blister packaging systems. A recent validation project we executed was for a 300 per minute blister packaging center.

The system consisted of: Uhlmann B 1240 c/w Systech-International Blister Vision Inspection System.

The services we supplied for this project included (1) review and modification of vendor supplied Installation and Operation Qualification Protocols for the blister machine and vision system, (2) execution of the protocols at the customer site, (3) preparation and execution of a Performance Qualification Protocol for the system as a whole, and (4) preparation of a Summary Report for final approval. (5) Preparation of Standard Operating Procedures (SOP’s). A total of 4 Protocols and 1 Summary Reports were produced for this project. Implementation was carried out in a timely manner according to a pre-established schedule and allowed the customer to start production on this system as planned.



SMB Validation & Compliance Group Inc. has provided validation support for numerous labeling systems, from many different manufacturers and integrators. A representative sample of recent projects is listed below:

1, NJM/CLI Model: 337LL II Commander Rotary Pressure Sensitive Labeler c/w NJM/CLI Model: 318 Strip Stik® Outsert Dispenser, NJM/CLI Model: 276 AutoSert Carousel, Open Date Model: EuroCode 300 Coder and Optel-Vision Model: OP 358 Code Inspector Vision System.

Services provided: URS, IO/Q, FAT, SOP and PQ.

2, Aesus Labeling Systems Model: 363P Inline Pressure Sensitive Labeler c/w Markem Model: Smartlase 110 Carbon dioxide laser and Optel-Vision Model: OP 358 Code Inspector Vision System.

Services provided: URS, IO/ OQ and PQ.

3, NJM/CLI Model: 363 AutoColt III Inline Pressure Sensitive Labeler c/w Open Date Model: Eurocode 300 Coder and Cognex Vision System.

Services provided: IO/ OQ.

4, EXA Systems Model: VLD 1800 Label Printing, Inspection and Reconciliation System c/w RVSI Aquity Vision System.

Services provided: DDS, FAT, IO/ OQ and SOP’s.

5, Quadrell Model: Q 10 Inline Pressure Sensitive Labeling System c/w Omron Model: F-350 Vision System.

Services provided: FAT, IO/ OQ and SOP’s.

6, DMW Ace Trac® Nude Vial Printing and Inspection System c/w Domino UV Ink-Jet Printer, and Systech Model: CX Vision System.

Services provided: FRS, IO/ OQ.



1, Large integrated Slat Filler Tablet filling and packaging line

A recent major validation project that the SMB Group completed was for a 400-bottle per minute tablet packaging line.

The line consisted of nine major pieces of equipment: Kaufman Automatic Gaylord Unloader, Omega Unscrambler, Lakso Slat Filler, Fowler-Zalkin Rotary Capper, Pillar Induction Sealer, Krones Labeler with Re-Torquing Heads, Skinetta Bundler, Boekels Checkweigher, and BelCor semi-automatic Case Erector/Packer.

The services we supplied for this project included (1) preparation of Installation and Operation Qualification Protocols for each machine as well as for the Data Highway System which monitored and controlled each piece of equipment on the line, (2) execution of the protocols at the integrator site (80%) as well as at the customer site (20%), (3) preparation and execution of a Performance Qualification Protocol for the line as a whole, and (4) preparation of all Summary Reports for final approval. A total of 18 Protocols and 19 Summary Reports were produced for this project. Implementation was carried out in a timely manner according to a pre-established schedule and allowed the customer to start production on this line as planned. Protocols were developed and partly executed in parallel with construction of the equipment thus saving time when the equipment was installed at its final location.


2, Large integrated Aylward Filler Tablet filling and packaging line

A recent major validation project for a 250-bottle per minute tablet packaging line consisted of fourteen major pieces of equipment: Pace UNI-SORT 300 Unscrambler, Aylward 710 Filler, Palace DF-MS Desiccant Inserter, APA StriPax Desiccant Pouch Dispenser, NJM/CLI Model: RotaCap Rotary Capper, Automate Model: AM-250 Induction Sealer, NJM/CLI Model: RTQ-150 Inline Retorquer, NJM/CLI Model: 337LL II Commander rotary labeler, NJM/CLI Model: 318 Strip Stik® Outsert Dispenser, NJM/CLI Model: 276 AutoSert Carousel, Optel-Vision Model: OP 358 Code Inspector Vision System, Open Date Model: EuroCode 300 Coder, Combi Packaging Systems Model: Alphapack 250 Automatic Packer and Case Erector, and NJM/CLI Model: 400 Case labeler.

The services we supplied for this project included (1) review and modification of vendor supplied Installation and Operation Qualification Protocols for each machine, (2) execution of the protocols at the integrator site as well as at the customer site, (3) preparation and execution of a Performance Qualification Protocol for the line as a whole, and (4) preparation of all Summary Reports for final approval. A total of 29 Protocols and 29 Summary Reports were produced for this project. Implementation was carried out in a timely manner according to a pre-established schedule and allowed the customer to start production on this line as planned. Protocols were developed and partly executed in parallel with construction of the equipment thus saving time when the equipment was installed at its final location.


3, Large integrated Aylward Filler Tablet filling and packaging line segment

RecentlySMB provided and executed protocols for a 200-bottle per minute tablet packaging line segment for a large multinational pharmaceutical company.

The line segment consisted of nine major pieces of equipment: Omega Model: 4D-RP2-15 Unscrambler/Desiccant Inserter, Aylward 715 DL Filler, NJM/CLI Model: TE-10 Tablet Elevator, BWI/Pneumatic Scale Model: MC-300-8 Rotary Capper, Enercon Model: SuperSeal Induction Sealer, NJM/CLI Model: RTQ-150 Inline Retorquer, NJM/CLI Model: AC326 AutoColt III labeler, Allen Model: ThermaCode Printer and Optel-Vision Model: OP 358 Code Inspector Vision System.

The services we supplied for this project included (1) preparation of Installation/Operation Qualification Protocols for each machine, using a customer supplied document format, (2) execution of the protocols at the integrator site as well as at the customer site and (2) preparation of all Summary Reports for final approval. A total of 9 Protocols and 1 Summary Report were produced for this project. Implementation was carried out in a timely manner according to a pre-established schedule and allowed the customer to start production on this line as planned and on budget.


4, Large integrated Swiftpack Filler Tablet filling and packaging line

A recent validation project SMB executed was for a 100-bottle per minute tablet packaging line.

The line consisted of eleven major pieces of equipment: IMA Nova Model: A300 Unscrambler, IMA Swiftpack Model: Twin SwiftVision Electronic Tablet Counters, IMA Nova Model: 150 Cottoner, Aesus Model: DL4C Inline Capper, Pillar Induction Sealer, Aesus Model: DL2C Inline Retorquer, MGS Corp Model: TopSerter, NJM/CLI Model: 125 Bronco Labeler, Optel-Vision Vision System, Omega Bundler and BelCor semi-automatic Case Erector/Packer.

The services we supplied for this project included (1) preparation of Installation and Operation Qualification Protocols for each machine, (2) execution of the protocols at the customer site, (3) preparation and execution of a Performance Qualification Protocol for the line as a whole, and (4) preparation of a combined Summary Report for final approval, (5) preparation of Standard Operating Procedures for each machine. A total of 19 Protocols, 1 Summary Report and 9 SOP’s were produced for this project.


5, Large integrated Cremer Filler Tablet filling and packaging line

The SMB Group recently provided protocols and execution services for a 100-bottle per minute tablet packaging line.

The line consisted of seven major pieces of equipment: Pace UNI-SORT 300 Unscrambler, AZCO Desiccant Pouch Dispenser, Cremer Model: CF 1220 D Twin Electronic Counters, NJM/CLI Model: UNICAP-150 Inline Capper, Pillar 2 KW Induction Sealer, NJM/CLI Model: UNI 300 Labeler, Cognex Vision System.

The services we supplied for this project included (1) preparation of Installation and Operation Qualification Protocols for each machine, (2) execution of the protocols at the customer site. A total of 14 Protocols and 1 Summary Report were produced for this project



Large liquid filling and packaging line

During a recent validation project we executed was for a 100-bottle per minute liquid packaging line.

The line consisted of: Omega Unscrambler, Kalish 12 nozzle Filler, Borgo Rotary Capper, Pillar Induction Sealer, Capmatic Labelstar Labeler, Polypack Bundler, and BelCor semi-automatic Case Erector/Packer.

The individual machines that were incorporated into this system were designed and constructed at multiple sites around North America and Europe. The system was integrated in Canada for a US based multinational and delivered for use in China.

The services we supplied for this project included (1) preparation of Installation and Operation Qualification Protocols for each machine, (2) execution of the protocols at the customer site in China. A total of 14 Protocols and 1 Summary Report were produced for this project.

The documentation and protocol execution were successfully completed to budget and on schedule.



1, Multiple Tablet presses and control systems

SMB Validation & Compliance Group Inc. provides validation support for development and production compression equipment and controls.

A recent example of this being a fully instrumented Manesty single stroke press for a product development lab followed by one (1) single sided Fette rotary press and three (3) double sided high speed rotary Fette tablet presses and automated control systems.

SMB fulfilled this multi-site contract providing IQ/OQ qualification protocols, FAT, SAT and Standard Operating Procedures and execution to budget and on schedule.


2, Courtoy Tablet Press and Control System

SMB Validation & Compliance Group Inc. provides qualification and compliance support for development and production compression equipment and their controls.

A recent example of this being a fully instrumented Courtoy Rotary Tablet Press for a product development lab of a large Japanese pharmaceutical manufacturer.

The services we supplied for this project included (1) preparation of Installation/Operation Qualification Protocols for the machine, (1) execution of the protocol at the customer site in the USA. The documentation and protocol execution were successfully completed to budget and on schedule.




Tablet Press Preventive Maintenance Procedure Audit

With 30 plus years of compression technology experience behind us SMB provides maintenance support for development and production compression equipment and their controls.

One recent example of the service we provide was a compression department maintenance audit during which, all unscheduled maintenance work orders for work performed on Manesty Unipress, Manesty Xpress, Fette 2090i, Fette 3200i and Kilian Synthesis 500 presses and control systems were reviewed and a cause/event/loss log prepared for each machine. This data was then compared to the preventive maintenance schedules with a view to identifying improvements, additions or modifications that could be introduced to the preventative maintenance program so as to reduce the frequency of unscheduled downtime.



Develop User Requirement Specifications (URS) for various equipment and lines.

User Requirements Specifications (URS) are prepared for each critical utility or piece of equipment prior to purchase. The specification provides a list of requirements for the planned system. The User Requirements Specification specifies the needs of the end user as well as any regulatory requirements. The document is provided to the supplier in order to ensure that all expected requirements, of the end user, for the utility or piece of equipment have been specified and supplied prior to the actual manufacturing stage. These specifications will be the basis for the Functional Requirements Specification and the Hardware and Software Specifications that detail the design of the utility or piece of equipment.

SMB has provided User Requirement Specifications for numerous projects, detailing the project requirements and resulting in the purchase of equipment from many different manufacturers and integrators.



Develop Functional Requirement Specifications (FRS) for various equipment and lines

Functional Requirements Specifications are required to protect both the end user and the manufacturer. All Requirements of the end user will be specified in the FRS prior to the manufacturing of the utility or piece of equipment. This enables the manufacturer to produce the product to the end user’s expectations. The manufacturer has the opportunity to review the FRS and incorporate the requirements in their system or offer alternatives to meet the requirement. Some requirements may not be possible to supply and therefore will be addressed prior to the manufacturing stage eliminating possible problems before they occur. The Functional Requirements Specification document may evolve with the project and is provided with a Revision History section in order to document any changes that occur throughout the project stages. The final version of the FRS will be a controlled document that can be referenced should any questions arise regarding the final product. The manufacturer must ensure that all aspects of the FRS have been understood and that all requirements can be fulfilled, or alternatives offered, in order to meet the end user’s expectations.

SMB has provided Functional Requirement Specifications for numerous projects, detailing the project requirements for various equipment purchased from various equipment manufacturers.




Develop Detailed Design Specifications (DDS) for various equipment and lines

Detailed Design Specifications (DDS) have been prepared for each critical utility or piece of equipment prior to the manufacturing stage. The specification provides a detailed description of the equipment design based on the Functional Requirement Specification (FRS) document. The DDS takes the functional requirements and detail how they will be manufactured in order to respect the requirements. The document is created in conjunction with/for with the manufacturer to ensure that every requirement will be respected as per the customer’s requirements. A Hardware and Software Specification section can be included in the DDS or a separate document for each can be created. Either way the hardware and software specifications for the utility or piece of equipment will be detailed.

SMB has provided Detailed Design Specifications for numerous projects, detailing the design of various equipment manufactured by many different equipment manufacturers.

Recent DDS projects include:
Fowler Zalkin. Model: CAS Capper, Proceco. Model: PECS Parts Washer. Aylward  Enterprises. Model: ACT 710 Tablet Counter, IMA Nova. Model: 300 Cottoner, IMA Swiftpack. Model: SV2 Twin Electronic Counter, IMA Nova. A300 Unscrambler, Serpa Packaging Solutions. Models: P100, P150 and P200 Cartoners, Econocorp. Model: EC125 Cartoner. EXA Systems. Model: VLD 1800 Label Printer, Reconciliation and Inspection System, Cremer 1220D Twin Electronic Counter.



Develop and execute Factory Acceptance Tests (FAT) for various equipment and lines

Factory Acceptance Tests are developed to protect both the end user and the manufacturer. The end user will only accept delivery of equipment once evidence that the piece of equipment, system, or integrated process is operating to their expectations and requirements. Documented evidence is provided by the FAT protocol to accept delivery of the equipment.

Failure of an FAT allows the manufacturer the opportunity to make the required changes at their facility to ensure that the equipment will operate to the specifications agreed to prior to the manufacturing stage. Failure to complete an FAT document could result in added costs to all parties involved due to service costs to the manufacturer and losses to the end user due to downtime and loss of production time. The FAT ensures that all questions and problems have been resolved prior to any merchandise being shipped. Final acceptance of the FAT results allows the manufacturer to deliver the piece of equipment, system, or integrated process to the end user.

Often the documented evidence/test data gathered during the FAT will be used as part of the Installation/Operation Qualification Protocol and thus reducing the time required to qualify the equipment after delivery.

SMB has provided Factory Acceptance Tests and execution assistance for numerous projects.

Recent FAT projects include:
Fowler Zalkin. Model: CAS Capper, Rota: Vial Filling and Sealing System. Aylward Enterprises. Model: ACT 710 Tablet Counter, IMA Nova. Model: 300 Cottoner, IMA Nova. Model: A300 Unscrambler, Serpa  Packaging Solutions. Models: P100, P150 and P200 Cartoners, EXA Systems. Model: VLD 1800 Label Printer, Reconciliation and Inspection System, NJM/CLI. Model: UNI 150 Capper, Aesus Packaging Systems. Model: DL-4C Capper. Optel-Vision. Model: OP358 Code Inspector.



Develop and execute Factory Acceptance Tests (SAT) for various equipment and lines

A Site Acceptance Test protocol provides documented evidence that a piece of equipment, system, or integrated process that has been delivered to the end user has not been affected in the transportation and has been adequately tested at the end user’s facility and performed to the end user’s expectations after installation. The SAT document will complete a series of verifications to ensure that what was ordered has been supplied by verifying the original purchase order and all specifications (URS, FRS, DDS) outlined, prior to the manufacture of the equipment, have been respected and incorporated on the installed product.

Control system verification will also be executed and documented in the SAT protocol. Performance testing will also be outlined and the results documented to provide assurance that the piece of equipment, system, or integrated process being tested meets the end user’s expectations and requirements and can move on to the next stage of qualifications required to validate the piece of equipment, system, or integrated process.

Recent SAT projects include:
Rota: Vial Filling and Sealing System, IMA Nova. Model: 150 Cottoner, IMA Nova Autosort 300 Unscrambler, Serpa  Packaging Solutions. Models: P100 Cartoner, EXAINC. Model: VLD 1800 Label Printer, Reconciliation and Inspection System, NJM/CLI. Model: UNI 150 Capper, Omega Design Corp-Bundler, NJM/CLI Model: 125 Bronco Labeler.



1, High Speed Nude Vial Printing and Inspection Systems

A recent project we executed was for a 600-bottle per minute Nude Vial Printing and Inspection System.

The system consisted of a DMW Ace Trac® Nude Vial Printing and Inspection System c/w Domino UV Ink-Jet Printer, and Systech Model: CX Vision

The system had two inspection stations. The first inspection station was used to inspect for empty product vials. The vision system camera would verify for product presence in each vial. All empty vials would be rejected in the first reject station. The second station had the Ink-Jet printer for printing a nine (9) digit human readable code onto the vial cap sleeve of various sizes, for purposes of vial trace-ability. The second inspection station was used to verify the code and would reject vials if the code was unreadable or stop the line if the code was incorrect.

The services we supplied were preparation of the Installation and Qualification protocols for the OEM.


2, Low Speed Nude Bottle Printing and Inspection Systems

A recent project we executed was for a 100-bottle per minute Nude Bottle Printing and Inspection System.

The system consisted of two EXA Systems Inc. Model: VLD1400P Bottle Handling Systems.

System one is installed at a manufacturing facility that packages Solid Dose product into HDPE bottles which are then capped and induction sealed. Each unlabeled bottle has an alphanumeric batch code and an electronically "scanable" 2-D DataMatrix format code applied directly to the base of the bottle. The applied codes are inspected for correctness and legibility. The purpose of the alphanumeric batch code is to allow for human visual confirmation of the product. The purpose of the electronically ‘scanable’ DataMatrix code is to allow high speed electronic verification of the product. Bottles with codes which fail any inspection attribute are rejected.

System Two is installed at a remote location from the manufacturing facility. The system verifies the correctness of both codes and provides a reject signal to a reject system in the event of a “missed read” or an “incorrect code”.

The services we supplied were preparation of the Installation and Qualification protocols for the OEM.



Flat Electrode Capacitor Stack Assembly (pacemaker)

SMB Validation & Compliance Group Inc. works with Medical Devices manufacturers for various projects that call for the design, engineering, manufacturing, commissioning and validation of custom-built machines to automate the manufacturing and testing of medical devices.

A recent example of this being a fully automated assembly system for components of an implantable cardiac defibrillator. The machines for this particular project included various punch sub-assemblies, multiple 2-axis and 3-axis robots, drivers, PLC, touch screens, instruments, etc.

The GAMP5 documentation and protocols execution were successfully completed to budget and on schedule.



Liquid packaging lines

A recent SMB Group validation project was for a 60-bottle per minute liquid packaging line.

The line consisted of: Kalish Filltronic liquid filler and an Aesus Model: DL4C Inline Capper.

The IQ/OQ/PQ documentation and protocol execution were provided for this project. Implementation was carried out in a timely manner according to a pre-established schedule and allowed the customer to start production on this line as planned. Protocols were developed and partly executed in parallel with construction of the equipment thus saving time when the equipment was installed at its final location in India.



Large Integrated Vial Control, Inspection and Packaging System

A recent SMB Group validation project for an integrated fully automated Vial Packaging System consisting of the following major component equipment: Advanced Digital Motion. Model: Vial Tray Unloader, Universal Machine Corporation Model: E100 Retorquer, ADM. Model: Vial Diverter/Collator/Robotic pick and place, Big Sky Engineering. Model: Vial/Clam Shell Packaging System and Optel-Vision Model: OP 355 Vision Inspection System.

The IQ/OQ/PQ documentation and protocol execution were provided for this project. Implementation was carried out in a timely manner according to a pre-established schedule.



Large Integrated Diagnostic Test Kit Assembly, Inspection and Packaging System

A recent SMB Group validation project was for is an integrated Diagnostic Test Kit Assembly and Packaging System consisting of the following major component equipment: Urania Engineering. Model: 3500P Pouching System Advanced Digital Motion (ADM). Pouch Loading Robot, Econocorp. Model: 7926. Cartoner, Westlund Literature Placer, Markem. Model: SmartDate. Thermal Transfer Printer and Optel-Vision Model: OP 358 Vision Inspection System.

The IQ/OQ/PQ documentation and protocol execution were provided for this project. Implementation was carried out in a timely manner according to a pre-established schedule.



Suspension Mixing systems

SMB Validation & Compliance Group Inc. provides validation support for process equipment and their controls.

A recent example of this being for a suspension mixer for a Biotech product development lab.

The SMB Group fulfilled this multi-site contract providing IQ/OQ/PQ qualification protocols, Standard Operating Procedures and execution to budget and on schedule.
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