Evaluation Of Environmental Monitoring Trending Status Formulation Rooms (November 2006 To December 2006)

INTRODUCTION

Enbrel’s Formulation Rooms: 485, 486 & 489 were monitored for viable particles in the air and surfaces as part of Environmental Monitoring Program with out of alert/action levels reported for the period of November 26, 2006 to December 03, 2006. The excursions consisted of the recovery of objectionable organisms including fungi and bacterial isolates on Slit to Agar (STA) airviable samples and Rodac (contact plates). These series of excursions triggered the initiation of Non-conformances (Refer to Table # 1). Table # 1 presents a summary of all the events that will be evaluated in this Trend Investigation (Attachment #1).

Table # 1: Excursions related with Enbrel’s Formulation Rooms.
|Excursion |Sampling Location |Sample Type|
|74629 |02/06/06 |Action Level exceeded with an objectionable organism (Mold) recovered from a STA sample. |
| | |Manufacturing and QA representatives were notified and the area was sanitized with Hypochlorite 1% on |
| | |02/09/06.|
| | |A definite root cause could not be identified. Nevertheless, the potential sources indicated that the |
| | |microorganism was introduced into the aseptic area by external sources other than the manufacturing process.|
|| |Event occurred in Room 486. |
|75906 |02/20/06 |Action Level exceeded with an objectionable organism (Mold) recovered from a Rodac sample. |
| | |Manufacturing and QA representatives were notified.|
| | |The area was sanitized on 02/28/06 with scheduled sanitizing agent (Coverage Plus) and monitored the same |
| | |day with satisfactory results (0 cfu/25cm2). |
| | |A definite root cause could not be identified.Nevertheless, the potential sources indicated that the |
| | |microorganism was introduced into the aseptic area by external sources other than the manufacturing process.|
| | |Event occurred in Room 486. |
|76574 |03/06/06 |Action Levelexceeded with an objectionable organism (Mold) recovered from a Rodac sample. |
| | |Manufacturing and QA representatives were notified. |
| | |The area was sanitized on 03/08/06 with Coverage Plus with satisfactory results (0 cfu/25cm2). |
| ||A definite root cause could not be identified. Nevertheless, the potential sources indicated that the |
| | |microorganism was introduced into the aseptic area by external sources other than the manufacturing process.|
| | |Event occurred in Room 483.|
|90945 |08/13/06 |Action Level exceeded for Total Count Test (result: 137 cfu/25cm2; Action Limit: 20 cfu/25cm2) recovered |
| | |from a Rodac-floor sample. The isolated microorganism was identified as Klebsiella oxytoca. |
| | |Manufacturing and QA representatives were notified....