SpotView®

Fiber-Optic System for Surface Analysis and Cleaning Validation

SpotView® detects, identifies, and measures thin organic coatings and films on solid surfaces such as sheet metal, glass, plastics, and paint. Objects such as computer hard drives and pharmaceutical reactor surfaces can be analyzed using a hand-held sampling head connected to a flexible fiber-optic cable which can be up to five meters long. Operation in the mid-infrared range enables non-destructive, in-situ examination of the surface of large objects using the well known technique of Fourier transform infrared (FTIR) spectroscopy. Specific materials, such as active pharmaceutical ingredients (APIs) can be identified and measured, even in the presence of other residues such as cleaning agents and excipients, and detection limits below 0.5 µg/cm2 can be achieved for a wide range of materials.

Schematic Drawing of the SpotView® Head

C O R P O R A T I O N

The combination of Remspec’s proprietary mid-IR fiber bundle technology with a specially designed probe head has led to a breakthrough in analytical capability. The probe head is engineered to deliver the mid-IR beam to the surface at the ideal “grazing” angle so that the maximum possible area is sampled by the beam. Mirror optics inside the head then deliver the signal directly to the on-board detector.

SpotView® is already in use for detection of cutting oil residues on large sheet-metal objects and inside precision valves, and is being introduced for pharmaceutical reactor cleaning validation.

Then.... Now

Cleaning Validation

A major application for SpotView® is in the field of cleaning validation for the pharmaceutical industry. Pharmaceutical reactors must be scrupulously cleaned between manufacturing or formulation runs. Validation of the cleaning process is an important and time-consuming process using current methods such as hand-swabbing of surfaces and later analysis of the swabs. SpotView® provides a direct method for analyzing critical surfaces in real time, using portable equipment with a compact, hand-held head and operator software that is compliant with CFR 21 Part 11. This could translate into enormous savings of down-time across the whole range pharmaceutical manufacturing.

SpotView™ spectrum of 0.74 μgcm-2

polystyrene on aluminum

SpotView™ spectrum of a 19 Ǻ layer of fluorocarbon lubricant on a computer hard

drive, compared with the spectrum of an unlubricated disk.

In a preliminary study of in-situ cleaning validation (BioPharm, 15 (5), 36-42, 2002), researchers from Remspec, the University of Puerto Rico, and Pfizer compared results from SpotView® spectra with results from an industry-standard swabbing method in a study of surfaces contaminated with low levels of a pharmaceutical ingredient. They showed that SpotView® gave results that were at least as good as the swabbing method in a fraction of the time and with fewer analytical steps.

Further work at the University of Canterbury and at Remspec (Org. Process R&D, 9, 337-343, 2005 and submitted for publication) has extended these results to sub-microgram surface loadings of multiple materials, including mixed APIs and cleaning agents. It has also been confirmed that SpotView® is highly effective for analyzing non-metallic surfaces such as glass and plastics like EPDM and silicone.

Cross-validation results for SpotView® detection of aspirin and acetaminophen applied as a mixture to a glass test coupon

SpotView® spectra of acetominophen at loadings of 0.3 (red) and 0.66 μgcm-2 on aluminum

Illustration 1Cross-validation results for SpotView detection of acetaminophen in the presence of aspirin

Figure 1: Cross validation results for aspirin on a glass surface in the presence of acetaminophen

Software

The SpotView® system includes a software package called CVal™ for CFR 21 Part 11-compliant operation. Procedures are set up and digitally locked by the Supervisor, then run by the Operator to generate locked and signed Results Reports.

The Supervisor sets up Procedures by building a list of procedural steps to be followed. Notes are added to direct the Operator where to place the SpotView® head, etc.

The results of SpotView® tests are automatically saved in digitally signed and locked Reports. An XML format is used and the Reports can be read using any available text reader, such as Microsoft Wordpad.

Remspec Corporation512 Leadmine Road, Sturbridge, MA 01566, USATelephone: 800-473-6773/+1 508 248-1462email: info@remspec.comwww.remspec.com

<?xml version="1.0" encoding="UNICODE"?><Date>2006/2/2</Date><Time>17:32:21</Time><Operator>CVal</Operator><Procedure>test11</Procedure><Method>C:\CVal\Calibration Files\Cattle LA01.q2</Method><Threshold>0.20</Threshold><Threshold Type>All Pass</Threshold Type><Series>

<Product Code>abc23</Product Code><Equipment ID>reactor1</Equipment ID><Lot Number>59b</Lot Number><Result>Fail</Result><Background>

<File>C:\CVal\Data\test11 20060202\test11 20060202173123.spc</File>

</Background><Data>

<File>C:\CVal\Data\test11 20060202\test11 20060202173142.spc</File>

<Value>0.58</Value></Data><Data>

</Series><Key>EwkGdb8TOYwiqn1tkkohI5cjidI=H</Key>