The Anatomy Of An Operational Test (OT) Script In Pen Assembly Validation

Article Summary: How do you prove a machine works? You script it. This article breaks down the anatomy of an Operational Test (OT) script used by DROFEN MACHINERY during the FAT, illustrating the precision and detail required to validate complex automated injection pen assembly systems.

 

When evaluating a pharmaceutical equipment vendor, CDMOs should ask to see their test scripts. The level of detail in an Operational Test (OT) script reveals the true engineering maturity of the company. A script that simply says "Run machine and observe" is a red flag.

 

At DROFEN MACHINERY, our OT scripts are the core of our Factory Acceptance Test (FAT) protocol. They are highly structured, step-by-step instructions designed to objectively prove that every sensor, servo, and software logic path in our injection pen assembly lines functions exactly as specified in the Functional Design Specification (FDS).

 

Every OT script in our FAT protocol (such as Test 1.01.02.01: Presence Check for Dose Cap + Challenge test) follows a strict, standardized anatomy:

 

1. Identification and Purpose The script begins with a unique Test Number (e.g., L.CC.SS.XX format, identifying the Line, Cell, Station, and Sequence) and a clear Test Purpose. It also lists the specific Sensor Numbers involved, providing immediate reference for the electrical engineers.

 

2. Prerequisites and Setup

Before the test begins, the script defines the necessary state of the machine. This typically includes ensuring all alarms are reset, the machine is in Auto Run mode, the master cam is at the "zero" position, and the relevant consecutive counters are reset.

 

3. Step-by-Step Procedure

This is the heart of the script. It breaks the test down into explicit, repeatable steps. For a challenge test, it might read:

 

4. Expected Results and Pass/Fail Criteria

For every step, there is a strictly defined Expected Result.

 

 

The tester must circle PASS or FAIL based on whether the actual machine behavior perfectly matched the Expected Result.

By utilizing this granular, step-by-step anatomy, DROFEN MACHINERY removes subjectivity from the validation process. The test either passes, or it fails and generates a Discrepancy Report. This level of rigorous, documented testing provides CDMOs and QA teams with the absolute confidence that their turnkey project has been thoroughly vetted, making their validation processes robust and great again.