Glossary

B

Bed Track

Format-specific supports to guide material between stations in the creation of blister packages. Typically provided as part of a blister tooling set.

Blisters Per Minute (BPM)

Unit for measuring blister machine output. Not to be confused with cycles per minute (CPM). Blisters per minute is the number of blisters the machine creates every minute. A blister machine can output a single blister or a number of blisters every complete machine cycle depending on the machine and web layout. For instance, a TF3 or TF2 blister machine can create multiple blisters at once if the blister is small.

BlisterMate

A semi-automatic blister packaging machine designed by Pharmaworks for R&D, stability runs and marketing samples.

Blister Package

A blister pack is any of several types of pre-formed, typically plastic or aluminum, packaging used for small consumer goods, medical devices, pharmaceuticals, foods and more. The primary component of a blister pack is a cavity or pocket made from a formable materials.

Blister Machine

Packaging equipment that creates blister packages using a form, fill, and seal process. Sometimes blister machines may be referred to as thermoformers.

C

Cartoner

A cartoning machine, or cartoner, is a packaging machine that forms and loads cartons: erect, close, folded, side-seamed and sealed cartons. Pharmaworks offers our Ci6 cartoner and other integrated solutions from Serpa, a Promach brand, to load blisters into cartons. Pharmaworks also offers rebuild and upgrade solutions for existing cartoner from other popular industry brands like Uhlmann, Marchesini, and more.

Current Good Manufacturing Practices

CGMP refers to the Current Good Manufacturing Practice regulations provided by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Changeover

The process of exchanging toolsets, change-parts, products, base and lid roll materials, and settings to run a different blister format. This process can be completed across different types of packaging equipment such as blister machines, feeders, fillers, cartoners, and more.

Cycles Per Minute (CPM)

A unit of measuring machine speed determined by the completion of a single cycle of equipment.

In the case of Pharmaworks single indexing blister machines such as the TF1, blisters are formed, filled, sealed and punched out during the course of a single cycle. Larger blister machines like the Pharmaworks TF3 utilize multiple indexers that run at two different rates to perform different parts of the blister packaging process.

It is important to remember that CPM, while related, is not necessarily equivalent to blister machine output or blisters per minute (BPM).

D

Decurler

A technology, blister station, or stand-alone piece of equipment that is used to reduce the curl that sometimes occurs during the blister manufacturing process.

Die Cut Station

One of the final stations in the blister packaging process. The die cut station is responsible for cutting out the final blister. Sometimes referred to as a punch station.

F

Factory Acceptance Test (FAT)

Part of the validation life cycle and an important part of a project timeline, FAT testing is used to determine if the purchased machine or equipment meets customer and/or industry requirements in the way of safety, performance, quality, and other criteria. FAT is completed at the OEM's facility by the customer. If the FAT is passed and successful, the machine is ready for shipment.

FAT tests can be informal testing where customers perform a general inspection and test run of the equipment or formal and extensive where test documents are executed. Pharmaworks offers complete documentation services including FAT documentation.

Feeders

Product feeders are responsible for supplying product to the blister machine during the packaging process. Feeders typically refer to product handling equipment that supplies solid-dose products, devices, and goods. Multiple feeding methods are available depending on the blister application. Methods such as pick & place, flood feeding, robotic handling, and more can be integrated with the blister packaging process. Pharmaworks provides multiple feeder models, custom solutions, and integration of third-party solutions.

Form Station

Blister cavities are formed at the Form Station. During the blister packaging process, the Form Station uses air and sometimes plugs to shape base material into the mold from form tooling. The process of forming heated material is known as thermoforming. Some materials and blister applications require plug assist functionality where plugs help stretch material while forming air is applied. Applications that use aluminum for the packaging material typically do not require heating. When material is formed without prior heating, it is known as cold forming.

Format (Blister)

A profile for the equipment that contains product-specific setup parameters for each station depending upon the layout of the blister packages.

Can also refer to the blister layout itself such as size, shape, and number of blisters that are created each index. Depending on the size of the blister and the machine format size, multiple blisters may be produced each machine cycle.

H

Human Machine Interface (HMI)

The HMI is typically a touchscreen system that allows users to make parameter adjustments and continuously monitor the equipment performance in real time.

I

Index

A single unit is equivalent to the length of material pulled through the blister machine each cycle. Index length can vary based on the blister format, blister layout, and machine model.

Indexer

Pharmaworks blister machines are intermittent motion machines that pull material through the process using indexers. Machines like the TF1, TF1e, and TF2 utilize a single indexer to pull material. The TF1pro and TF3 utilize two indexers running at different speeds to pull material through the blister machine.

Installation Qualification (IQ)

As part of the validation life cycle, IQ is performed once the machine has been installed and after the customer has completed any site acceptance testing. Pharmaworks offers Installation Qualification documentation services. Installation Qualification typically includes utilities testing, component verification, wiring verification, and other testing. Successful completion of the IQ is a pre-requisite to Operation Qualification.

L

Lowerator

A station that works in conjunction with the Die Cut Station. As blisters are cut or punched, the Lowerator utilizes vacuum cups to hold and transfer blisters down to the outfeed conveyor. The Lowerator allows for additional control and handling.

O

Operation Qualification (OQ)

As part of the validation life cycle, OQ is performed once Installation Qualification is complete. Pharmaworks offers Operation Qualification documentation services. Operation Qualification typically includes user security testing, HMI testing, alarm verification, test runs, and other testing. Successful completion of the OQ is required prior to Performance Qualification and/or production.

Outfeed

Refers to the outfeed conveyor of a machine. Outfeed conveyors transport final products, typically blisters in our case, from the machine to bins or transfer conveyors for downstream processing. Pharmaworks offers multiple outfeed conveyor options for our blister machines. Many times, an outfeed conveyor can be installed to transfer blisters out the front, rear, or inline with the machine. Various types of outfeed conveyors are also offered including continuous motion, indexing, and even retracting conveyors that handle the blister rejection process.

P

Perforator Station

The perforator station applies perforations to blisters using blister format-specific tooling.

Preheat Station

The preheat station heats material prior to the forming process on a blister machine. The preheat station consists of upper and lower preheat plates that heat base material, typically plastics like PVC, making it suitable for forming blister cavities. Not all base materials require heating prior to forming such as aluminum.

Product Handling

Product handling systems supply various forms and types of products to blister packaging machines. Product handling technology is capable of supplying solid dose products like tablets, capsules, and gel caps or other forms of products like liquids, powders, medical devices, and other consumer goods. Such systems are also referred to as Feeders. Pharmaworks offers multiple feeding solutions across our line-up of fully automatic blister machines.

Q

Qualification

As part of the validation life cycle for equipment, customers must qualify equipment before production. There are multiple stages to qualification. Qualification occurs after Site Acceptance Testing (SAT) has been completed. Pharmaworks offers Installation Qualification and Operation Qualification test documentation for this phase of testing.

R

Rebuilds & Upgrades

A service offered by Pharmaworks where older machinery is disassembled, refurbished, reassembled and upgraded to varying degrees. Modernizing equipment is an option for many customers who have already invested in a blister packaging solution. Pharmaworks can rebuild blister machines, cartoners, and other equipment from other popular industry brands such as Uhlmann, Klockner, Pentapack and more.

S

Scanware Vision Inspection Technology

Scanware provides world-class vision inspection systems. Pharmaworks is the North American supplier of Scanware vision inspection systems and integrates Scanware solutions with our blister packaging technology for product and print inspection.

T

Thermoformer

A machine that heats materials to form into different shapes or packages, in our case blister packs. Blister machines, in general, are commonly referred to as thermoformers.

Tooling

Unique format-specific dies and molds used for creating blisters. Tooling is used for handling, guiding, forming, sealing, perforating, cutting material, etc. For feeders and product handling systems, tooling is used to guide and handle different products for different blister formats. Pharmaworks provides tooling for our blister machines, feeders, and other third-party equipment from other popular industry brands such as Uhlmann, Klockner, and more.

V

Vision Inspection System

A computer-based system with a camera capable of processing an image to analyze different characteristics of products, prints, and codes. Vision inspection systems are used to check for a wide variety of failures such as broken product, wrong color product, missing product, OCR inspections, missing lot/date codes, and more.

Vision inspection systems can be integrated with blister packaging machines or on stand-alone inspection equipment like the Pharmaworks VIS and IBIS inspection machines. Pharmaworks is the North American representative for Scanware vision systems. Pharmaworks also has developed our own QC vision inspection systems.

W

Waste Shredder

Waste shredders use a rotating knife assembly to cut left-over material into small pieces. Pharmaworks uses waste shredders standard on many of our automatic blister packaging solutions and offers it as an aftermarket upgrade for third-party blister packaging equipment.

Waste Rewind

An alternative to handling waste material, a waste rewind neatly collects material left-over from the blister packaging process and rolls it up on a spool for easy removal.