AROUND LAB NEWS

𝐀𝐬𝐞𝐩𝐭𝐢𝐜 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐢𝐧𝐠, 𝐭𝐡𝐞 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐞 𝐩𝐚𝐭𝐡
𝑃𝐷𝐴 100 𝑖𝑛 𝐵𝑒𝑡ℎ𝑒𝑠𝑑𝑎, 𝑠𝑒𝑐𝑜𝑛𝑑 2026 𝑠𝑒𝑠𝑠𝑖𝑜𝑛

📅 12–16 October 2026

From 12 to 16 October PDA runs the second 2026 session of its Aseptic Processing Training Certificate Program, PDA 100, in Bethesda. It is a certificate path, not a two-day update: further sessions follow in November and December (https://ow.ly/tFqG50ZOJH2).

🔗 https://ow.ly/KVrv50ZOJH1

More verified dates on the Around Lab News events calendar: https://ow.ly/PMN950ZOJH3

Six size channels, two of them regulatory.

ISO 14644-1 and Annex 1 classify cleanrooms on 0.5 µm and, for the sterile grades, 5 µm. The other channels a counter reports do different jobs: 0.3 µm for filter leak scanning and electronics-grade air, 1.0, 2.5 and 10 µm for the PM fractions used in indoor air quality and occupational hygiene. Counts at 5 µm mostly come from people, not from the HVAC, so a trend there is a behaviour signal.

One instrument, several questions. State which channel answers which.

https://ow.ly/uhzw50ZOJAY

𝐏𝐫𝐞-𝐟𝐢𝐥𝐥𝐞𝐝 𝐬𝐲𝐫𝐢𝐧𝐠𝐞𝐬 𝐢𝐧 𝐏𝐚𝐥𝐦 𝐒𝐩𝐫𝐢𝐧𝐠𝐬
𝑡ℎ𝑒 𝑃𝐷𝐴 𝑈𝑛𝑖𝑣𝑒𝑟𝑠𝑒 𝑐𝑜𝑛𝑓𝑒𝑟𝑒𝑛𝑐𝑒, 𝑡ℎ𝑒𝑛 𝑎𝑛 𝐴𝑛𝑛𝑒𝑥 1 𝑤𝑜𝑟𝑘𝑠ℎ𝑜𝑝

📅 6–7 October 2026

The PDA Universe of Pre-Filled Syringes and Injection Devices Conference meets in Palm Springs on 6–7 October, with an Annex 1 Implementation Workshop scheduled after the conference (https://ow.ly/kJSU50ZOJG3).

🔗 https://ow.ly/uN0P50ZOJG1

More verified dates on the Around Lab News events calendar: https://ow.ly/kCKJ50ZOJG2

The standard asks for a volume, not a flow rate.

ISO 14644-1 says: at each location, sample enough air to count 20 particles if the room were at the class limit, with a minimum of 2 litres and one minute. For ISO 7 and ISO 8 at 0.5 µm the 2-litre floor is what applies, so any calibrated counter does it in a minute. For ISO 5 at 0.5 µm it is 5.7 litres. Only Grade A at 5 µm, with the Annex 1 limit of 29/m³, needs 690 litres and calls for a 28.3 L/min instrument.

Match the counter to the room, and put the volume in the report.

https://ow.ly/gFm950ZOJFQ

When the monitoring plates were never collected.

In 2026 the FDA sent a Warning Letter to Reliance Life Sciences, Navi Mumbai. Among the findings: environmental monitoring plates recorded as collected and incubated that could not be found in any incubator, colony counts entered as if incubation were under way, and LIMS calculations without the dilution factor. The contamination control programme was judged not functioning and the site is under Import Alert 66-40.

Not a limit exceeded. Data that did not exist.

https://ow.ly/KSrg50ZOJsn

Alert levels are not limits.

Annex 1 defines the alert level as an early warning of drift, always below the action level and derived from your own historical and qualification data, reviewed over time. The regulatory table gives the action levels. The alert levels have to come from the site. The Annex then asks for trends: increasing breaches, consecutive alerts, repeated isolated actions with a common cause, changes in microbial flora.

A level copied from the table detects failure. A level derived from data detects drift.

Application note N.108: https://ow.ly/879e50ZOJnr

POWTECH TECHNOPHARM closes the month in Nuremberg, 29 September to 1 October 2026.

Powders, solids and pharmaceutical process across three days. Cleanroom enters the picture wherever the product is exposed, between containment, handling and solids treatment.

We keep the calendar, verified event by event.

https://www.aroundlab.org/

𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝐨𝐩𝐞𝐧𝐬 𝐢𝐧 𝐌𝐢𝐥𝐚𝐧
𝐶𝑃𝐻𝐼 𝑐𝑜𝑚𝑒𝑠 ℎ𝑜𝑚𝑒, 𝑤𝑖𝑡ℎ 𝑎 𝑐𝑜𝑛𝑡𝑎𝑚𝑖𝑛𝑎𝑡𝑖𝑜𝑛 𝑐𝑜𝑛𝑡𝑟𝑜𝑙 𝑧𝑜𝑛𝑒

📅 6–8 October 2026

CPHI returns to Fiera Milano on 6–8 October. For the first time the show has a dedicated Contamination Control zone next to APIs, machinery and packaging, and a Sustainability Summit runs alongside on 6–7 October (cphi.com). For a QC microbiologist it is the one week of the year when the cleanroom supply chain is within a tram ride of the office.

🔗 https://www.cphi.com/europe/

More verified dates on the Around Lab News events calendar: https://www.aroundlab.org/

The third VDI course of the month, in Frankfurt.

Cleanrooms under GMP on 29 and 30 September 2026, with Annex 1 and qualification at the centre of the programme.

We keep the calendar, verified event by event.

https://www.aroundlab.org/

Is your classification data defensible?

A cleanroom class is a number produced by a particle counter. ISO 14644-1 requires that counter to be calibrated under ISO 21501-4: size setting within ±10%, counting efficiency 50% ±20% at the first channel, flow rate within ±5%, false counts no more than 1 in 5 minutes, calibration at least once a year. And the certificate should show traceability to the SI with a stated uncertainty, as ISO/IEC 17025 requires.

Without that, the class is an opinion.

https://ow.ly/pGny50ZOJ6B