AZtecPharma

The Pharmaceutical and Biomedical industries require EDS systems to show that their electronic records are trustworthy, reliable, and equivalent to paper records. AZtecPharma is designed to meet the growing requirements of the Pharmaceutical and Biomedical industries with:

Individual user login
Digital signatures
Data Audit Trail with viewer
Data tree deletion forbidden

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AZtecPharma is a dedicated version of the market-leading AZtecLive software platform with increased data security and integrity. It enables EDS analysis to be incorporated into laboratory Standard Operating Procedures to support good practice quality guidelines like ‘GxP’ and regulations such as 21 CFR part 11 and Annex 11

Secure

Individual user logins, making use of existing company login credentials
Local IT can continue to set user privileges

Accurate

Advanced Tru-Q® spectrum processing technology ensures that peaks are automatically identified and labelled, enabling even inexperienced users to achieve reliable sample and feature determination
Even a novice user can achieve expert results consistently

Traceable

Data interactions are stamped with digital signature
Dedicated ‘Inspector’ program used to view ‘Audit-Trail’

Individual User Login

Users must login to use AZtecPharma
AZtecPharma uses existing company login credentials
Local IT can set user privileges and password change interval

Digital Signature

Data interactions are stamped with ‘user name’, ‘action’ and ’date/time’
Digital signature cannot be modified or removed

Audit Trail and Inspector

Dedicated ‘Inspector’ program used to view ‘Audit-Trail’
Filter records on individual user, project or date/time
Audit trail cannot be modified

Live Chemical Imaging

Increased Productivity
Increased Confidence

SOPs and Profiles

Import existing SOPs into the AZtecPharma profile
Each profile saves all acquisition conditions

Cross-section of a pain relief tablet

Cross-section of a drug packaging

Analysis of contamination from an actuator

Applications

Figure - Example of live spectrum compare - In yellow the currently acquiring spectrum from the sample being analysed and in red is the spectrum from the control sample. This view immediately tells the analyst if there is an issue

Main applications carried out in Pharmaceutical production facilities are Quality Control and Failure Analysis

Quality Control is often a simple check on the structure and chemical composition of the product. Using AZtec’s live spectrum compare is an ideal way of comparing a sample's composition with control. Any sample that deviates from the control will be submitted for more detailed Failure Analysis.

*Example of live spectrum compare - In yellow is the currently acquiring spectrum from a sample being analysed and in red is the spectrum from the control sample. This view immediately tells the analyst if there is an issue

Common areas of analysis

Product

• Material from 3rd party supplier may contain contamination from numerous sources (Metals, plastics, glass, ceramics, fibres)

• Production process

• Cross-contamination from other products using same facility

• Contamination from equipment (metals, plastics, paint, oils etc…)

• Human contamination

Packaging

• Contaminated blister packs, tubes, jars and boxes

Drug Delivery Equipment

• Defective Actuators and syringes

Product

Foreign body identification in products is the most common application. Whether it’s from the raw materials or the production process; Tracing the contamination back to source is key to preventing future occurrences. This contamination can cause the product to fail or in the worst case, cause harm to the consumer. In the example below, an initial investigation was carried out using AZtecLive Chemical Imaging to get a quick overview of the tablet structure and composition. Then a more detailed analysis was carried out using spectrum compare and then X-Ray mapping.

Movie showing the initial investigation using AZtecLive Chemical Imaging

Layered image showing the chemical distribution over the cross section of a pain relief tablet

Packaging

Packaging can be a source of contamination or be defective in a way that it allows external contamination of the product it encloses

Movie showing an initial investigation can be carried out using AZtecLive Chemical Imaging

Layered image showing the chemical distribution over the cross section of cellulose packaging

Drug Delivery Equipment

The drug delivery mechanism can also be a potential source of contamination, for example:

· Failure of Asthma Cannister causing contamination fragments to contaminate the drug actuations

· Failure of vials and syringes resulting in glass contamination

Detection of Al contamination particles from a defective inhaler

Actuation from an Asthma inhaler

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