Aseptic Tracking and Foolproof Quality Control:Digitized and Automated Chain of Custody and Audit Information at Your Fingertips — Anywhere

The ChallengeEvery pharmaceutical manufacturer lives in fear of becoming front page news by committing product safety violations. Federal Regulation, Title 21, is an FDA standard governing the food and drug industries in the United States. It specifies the criteria for compliance with Current Good Manufacturing Practice (CGMP), and is meant to help manufacturers validate clean rooms, test clean room assets, and monitor microbiological and pharmaceutical processes. Environmental monitoring is the first line of defense for ensuring contamination-free production environments and product fitness for release. Compliance with CGMP requires stringent process control and record keeping, which can add cost and time to the production of parenteral drugs.

Scope of Clean Room Manufacturing and Environmental MonitoringThe rising demand for biopharmaceuticals and advantages of single-use sampling products are driving the rapid growth of the aseptic sampling market. The market is expected to grow at a compound annual growth rate of 13.5 percent through 2023. In addition to growth, the industry is looking for ways to reduce the cost of installation, decrease risk of product cross-contamination, and facilitate fast implementation.

Most manufacturers today use paper-based methods to support sample collec-tion in quality control (QA) programs. Only an estimated 15 percent of the mar-ket utilizes more automated methods like bar codes. Lack of digital solutions and reliance on paper and pencil means the manufacturing floor is error-prone, and that the most critical monitoring activities are time- and labor-intensive.

Solutions that digitize, automate, and provide chain of custody and audit trail information for all sterilized materials, products, and assets coming into and being used in the manufacturing process can greatly assist the efforts of QA programs. Furthermore, digital solutions can improve manufacturing effective-ness and facilitate reporting for environmental monitoring. In an industry where risk is synonymous with heavy financial impact and potentially even the risk of human life loss, all measures that facilitate accurate environmental monitoring and improve operational excellence are of first-order importance.

The SolutionTego’s award-winning Asset Intelligence Platform (AIP) is uniquely suited for success in this challenging and stringent environment. With the world’s only sterilization-proof ultra-high frequency (UHF) Radio-Frequency Identification (RFID) chip, Tego AIP provides an enriched sample and asset management system that meets the rugged demands of aseptic manufacturing and CGMP. Tego AIP creates and manages a full digital history of samples, reporting its entire lifecycle, workflow, and chain of custody. This history begins prior to manufacturing, spans its duration and aftermath, and captures critical data throughout the environmental monitoring process.

See the Tego Connect Mobile and TegoHub in action.

www.tegoinc.com

Tego’s sterilization proof asset tracking solution is proven to withstand:

• Gamma sterilization

• eBeam sterilization

• Ethylene oxide sterilization

• Cold storage (-80C)

1

Tego Connect Mobile allows workers to digitize location, associations, batch, and

identification information directly on samples gathered during environmental monitoring.

Tego Hub provides a centralized data base accessible through a web-based application for dashboard viewing, management of rules for field notification, automated reporting, and solution configuration.

www.tegoinc.com 2

Tego Connect Mobile

Tego Hub

Tego Connect Mobile on TSL model

Tego Connect Mobile on Zebra model

www.tegoinc.com 3

By virtue of its revolutionary and patented storage technology, Tego solution automates, reports and synchs the entire workflow of a sample’s critical information and processes through its QA life cycle stages. The data is accessible via smart phone application, portable device (tablet, etc), or can be read using an autonomous reader that is placed strategically in one or multiple locations.

The digital data collected on any asset is virtually unlimited. It can include batch, workflow step or stage, explicit processes for compliance, expiration dates, and any other attributes that are relevant and critical to the workflow.

Data is transmitted and backed up to the TegoHub, an enterprise database and web-based application managed by the Tego platform. TegoHub can be configured to interface with other systems such as LIMS or BMS (building management), extending the reach and usefulness of the asset data. The platform can be configured for almost any workflow that streamlines labor intensive processes and closes gaps where documentation does not exist and where manufacturers and QA programs are often challenged. For example, it supports with real-time data, where assets move through sterile workflow processes and provide alerts should movement of assets present potential for contamination. More specifically, the platform can be configured to automate the following use cases:

• Digitization of manufacturing room logbooks

• Media lifecycle for use during contamination events (used or unused media)

• Equipment usage and clean room location management

• Material/waste/product/equipment flows

• Chain of custody for batches and related documents

How it WorksOn the manufacturing floor, a sterilization-proof, passive UHF label or tag is serialized with a material’s, sample’s, or asset’s critical information, requirements for quality assurance tracking, reporting, and auditing. As these items move throughout their life cycle, each stage of workflow is captured serially and stored in the label or tag, building up a digital chain of custody on the asset itself, reporting movement, condition, workflow steps, etc.

Digital information is automatically synchronized with the centralized TegoHub database. TegoHub reports individual item and aggregated data, has configurable dashboards, automated reporting capability, workflow definition, and rule management for alerting and notification in real time. Emails, text messages, or scheduled reports are sent automatically from TegoHub to the people who need to know as events happen and rules trigger automatic reporting.

Benefits

QUALITY CONTROL

Automate data collection from devices and people

Eliminate redundancy data entry and transcription errors

Gain direct traceability of QC Micro programs

Improve worker efficiency

Improve regulatory compliance

Make sound product and quality release decisions

OPERATIONAL

• Accurate, secure, and automated digitized data flowing directly from the manufacturing room floor into LIMS, BMS, MES, etc

• Automated alerting and event reporting based on workflow movement of aseptic materials, samples, and assets

• Personnel monitoring in real time

ROI

Digitizing materials, samples and asset results in a fifty percent reduction in labor intensive sample collection activities

Improved regulatory compliance and reduced risk in turn reduce financial penalties

Better reporting for FDA speeds time to market

WITHOUT TEGO'S SOLUTIONS

Manual paper and pencil process steps burden QC programs with paper scheduling, market labeling of sample media, manual reconciliation, paper log book entry, and manual notification of deviations. Moreover, test results are stored in shelves of paper binders – a challenge to navigate in an audit.

50%

Tego PlatformAseptic manufacturing powered with Tego’s award-winning Asset Intelligence Platform (AIP), complete with mobile device applications and centralized cloud accessibility and reporting.

Find out how your organization can eliminate inefficiencies and save significant costs by leveraging a turnkey solution to transform its supply chain and improve

visibility across the organization. Contact Us Today.

Powering Assets with Intelligence www.tegoinc.com

Platform Advantages• Quick and inexpensive

deployment

• Minimal new infrastructure requirements

• Universally deployable on any type of product, packaging, part or component

• Open and multi-platform, Tego’s mobile device application supports all major mobile and desktop operating systems, including iOS, Android, Windows and OS X

• Tego operates across all RF gateway protocols and handheld readers

• Scalable to any environment and size of operation

• Capable of standalone deployment without complex integrations

• Integration with inventory management systems or EAM modules, through a library of APIs

• Configurable to customer requirements

• Easier sharing of data across systems

460 Totten Pond Road | Suite 720Waltham, MA 02451 USA |  t: +1 781.547.5680

The solution enables automated tracking of clean room materials, samples and assets for less labor-intensive activities, better visibility and reporting, and reduces overall contamination risk on the manufacturing floor.