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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 

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.

Figure - Movie showing the initial investigation using AZtecLive Chemical Imaging
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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