# Cleanroom Environmental Monitoring Log Worksheet > Source: https://netray.co/tools/cleanroom-environmental-monitoring-log-worksheet > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer An editable log for environmental monitoring counts per location and grade with an automatic percent of limit and excursion flag. ## Category quality ## Industry Pharmaceutical ## Audience - Microbiologist - QC analyst - QA officer ## Tool **Kind:** worksheet **Mode:** editable **Columns:** #### Date **Key:** date **Type:** date #### Sample location **Key:** location **Type:** text #### Grade **Key:** grade **Type:** select **Options:** - A - B - C - D #### Method **Key:** method **Type:** select **Options:** - Active air (cfu/m3) - Settle plate 90 mm (cfu/4 h) - Contact plate 55 mm (cfu/plate) - Glove print (cfu/glove) #### Count (cfu) **Key:** cfu **Type:** number #### Action limit **Key:** limit **Type:** number #### Percent of limit **Key:** pct **Type:** number **Expr:** if(gt(limit,0),cfu/limit*100,if(gt(cfu,0),100,0)) **Format:** percent #### Excursion (1 = yes) **Key:** excursion **Type:** number **Expr:** if(gt(cfu,limit),1,0) **Format:** integer #### Organism ID **Key:** organism **Type:** text **Rows:** **Date:** 2026-10-12 **Location:** Fill zone, point 1 **Grade:** A **Method:** Settle plate 90 mm (cfu/4 h) **Cfu:** 0 **Limit:** 0 **Date:** 2026-10-12 **Location:** Background to filling line **Grade:** B **Method:** Active air (cfu/m3) **Cfu:** 3 **Limit:** 10 **Organism:** Micrococcus luteus **Date:** 2026-10-12 **Location:** Stopper bowl wall **Grade:** B **Method:** Contact plate 55 mm (cfu/plate) **Cfu:** 6 **Limit:** 5 **Organism:** Staphylococcus epidermidis **Date:** 2026-10-13 **Location:** Compounding room floor **Grade:** C **Method:** Contact plate 55 mm (cfu/plate) **Cfu:** 8 **Limit:** 25 **Organism:** Bacillus sp. **Date:** 2026-10-13 **Location:** Gowning room, exit **Grade:** D **Method:** Active air (cfu/m3) **Cfu:** 40 **Limit:** 200 **Totals:** #### Excursions in log **Key:** excursion **Agg:** sum **Format:** integer #### Highest percent of limit **Key:** pct **Agg:** max **Format:** percent #### Samples logged **Key:** cfu **Agg:** count **Format:** integer **Notes:** Typical EU GMP Annex 1 (2022) recommended action limits for grade B are 10 cfu/m3 air, 5 cfu/4 h settle plate and 5 cfu/plate contact. Grade C: 100, 50, 25. Grade D: 200, 100, 50. Grade A requires no growth. Use your own validated alert and action levels where they are tighter. ## Content **Intro:** Environmental monitoring (EM) data is only useful when you can see it in order, against its limit, and spot trends. This worksheet gives microbiology and QA teams a clean log with limits, percent of limit and a clear excursion count that exports to Excel. **Sections:** #### How to use the log **Body:** Add one row per sample. Pick the grade and method, type the count and the action limit from your EM procedure, and add the organism ID when available. Percent of limit and the excursion flag are calculated for you. Grade A results above zero need immediate review. Sort or filter the exported Excel by location to see repeated hits at the same point, which is the early sign of a trend. **Bullets:** - Keep one row per plate, not per room per day - Record the organism for every count, especially in grades A and B - Copy limits from your approved SOP, not from the notes #### Limits and standards behind it **Body:** Annex 1 of EU GMP (revised 2022) gives recommended limits for microbial contamination per grade, and ISO 14644 covers particle classification, which is a separate monitoring stream. The limits in the notes are recommended maxima, and sites set their own alert and action levels based on historical data and risk. Alert levels trigger a review of trend, action levels trigger an investigation. This worksheet uses a single limit column so you can use whichever you track. #### Reading the result **Body:** In the example, the stopper bowl wall contact plate shows six cfu against a limit of five, which gives 120 percent and one excursion. That would start an investigation covering the operators present, cleaning records and the organism's likely source. A string of results at 70 to 90 percent of limit in a grade B room is not an excursion but should be discussed at the monthly trend review. **Bullets:** - Flag repeat organisms at the same location - Check any excursion against the batch in process at the time **Cta:** If EM results sit in a LIMS or spreadsheets and you want trend charts and batch impact checks against ERP production orders, Netray can help build it on your own infrastructure. **Faq:** #### Are the limits in the notes mandatory? **Answer:** They are the recommended limits in EU GMP Annex 1 (2022). Your site may use stricter alert and action limits based on trend data. Regulators expect justified limits in the contamination control strategy, not a copy of a table. #### Does this replace a LIMS? **Answer:** No. It is a simple log for small sites, trials and trend discussions. For regulated records you need audit trail, secure access and controlled calculations in a validated system or controlled paper process. #### What do I do for a grade A count above zero? **Answer:** Treat it as an event requiring immediate investigation under your procedure, including identification of the organism and assessment of batch impact. Do not wait for the monthly trend meeting. #### Should particle counts be in this log? **Answer:** Keep them in a separate log or system because the units and limits are different. Non viable particle monitoring follows ISO 14644 classes and the Annex 1 particle limits for each grade. ## Search terms environmental monitoring log excel, cleanroom monitoring record, settle plate log template, em trending worksheet, grade b cfu limit, annex 1 em limits, viable monitoring log --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json