Deblistering Machine Qualification
Overview
A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not related to product quality (e.g.… more
Qualification of Cell Culture Purification Suite
The Challenge
A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window.
Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their quality control lab facility, and changes to their utility systems to accommodate the resultant increased production rates.… more
Packaging Line Qualification
The Challenge
A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow for continued packaging operations during construction and qualification activities.… more
Greenfield Capital Expansion Project
Challenge
A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:
- Compressed Air Generation and Distribution
- Nitrogen Distribution
- Process Alcohol Distribution
- Plant Steam Generation
- Pure Steam Generation and Distribution
- Vapor Compression Distillation Pretreatment Unit
- Two (2) Vapor Compression Distillation Units
- Cold Water for Injection Distribution
- Hot Water for Injection Distribution
- Purified Water Distribution
- Drive-in Refrigerator
- Three (3) Walk-in Refrigerators
- One (1) Walk-in Freezer
- One (1) Drive-in Freezer
- Two (2) Reach-in Freezers
- Ten (10) Air Handling Units
- Three (3) Facility Management Systems
Solution
Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations.… more
Qualification of Continuous Manufacturing Suite
Continuous Manufacturing Process Train Qualification
The Challenge
A Pharmaceutical Manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a continuous manufacturing process train. The process train was the first commercial continuous manufacturing suite for the company.… more
Blister Card Packaging Line Qualification
The Challenge
A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line.… more
Non-Destructive Leak Test
The Challenge
A Midwestern pharmaceutical company planned to upgrade their in-process checks for blister card integrity from a destructive blue dye leak test to a non-destructive, vision system-based leak test. The existing blue dye leak test required that all tested blister cards be discarded even if they passed.… more
Building Management System
The Challenge
A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration. … more
Finished Drug Product Distribution Warehouse Commissioning
The Challenge
A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis. The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area. … more
Automated Product Storage and Retrieval System
Pharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q
The Challenge
A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration as well as reduce risk for human error when handling the product on fork trucks.… more