# Article: BPOM Cleanroom Requirements for Pharmaceutical Plants in Indonesia

## Brief Introduction
CPOB / BPOM cleanroom standards for Indonesian pharmaceutical manufacturing — Grade A/B/C‑D classification, pressure, airflow, HEPA testing, common audit non‑conformities.

## Main Content


If you are building or upgrading a pharmaceutical plant in Indonesia, the cleanroom is one of the first things BPOM (Badan Pengawas Obat dan Makanan) will inspect — and one of the easiest things to get wrong. You will not receive your production license (Izin Produksi Obat) until it passes.



The good news is that BPOM does not enforce a secret Indonesian-only standard. It enforces CPOB (Cara Pembuatan Obat yang Baik), which is aligned with ASEAN GMP and WHO GMP. The current standard is PerBPOM No. 7 of 2024. If your cleanroom already meets EU GMP Annex 1 and ISO 14644, you are most of the way there. The rest comes down to documentation and local inspection practice.

One naming point that trips up foreign contractors: CPOB applies to conventional pharmaceuticals. CPOTB (with a "T") is for traditional medicines and follows a lighter, different framework. If your product is a drug, API, sterile injectable, vaccine, or IVD, CPOB is what applies to you.
Which cleanroom class does my product need?
For sterile manufacturing, CPOB divides the facility into four zones — Grade A, B, C, D — which map directly to ISO 14644.

For sterile manufacturing, CPOB divides the facility into four zones — Grade A, B, C, D — which map directly to ISO 14644.GradeISO class (at rest)Typical useParticle limit at rest (per m³)Grade AISO 5Filling, capping, open vials, sterile connections, any exposed‑product critical zone — under unidirectional airflow≥0.5 µm: 3,520
≥5.0 µm: 20Grade BISO 5The room surrounding the Grade A zone (aseptic filling room itself)≥0.5 µm: 3,520
≥5.0 µm: 29Grade CISO 7Less critical sterile support areas: solution preparation before terminal sterilization, equipment washing≥0.5 µm: 352,000
≥5.0 µm: 2,900Grade DISO 8Gray areas: component washing, preparation of products to be terminally sterilized≥0.5 µm: 3,520,000
≥5.0 µm: 29,000

These are the at-rest numbers. The in-operation limits — measured while operators are actually working and equipment running — are tighter, and that is what your continuous monitoring is judged against.The physical parameters inspectors actually measure

Do not design to the particle table alone. Inspectors verify the system that keeps those particles down.

Unidirectional airflow over Grade A. The critical zone needs a unidirectional airflow hood (LAF, or RABS for higher-containment products), typically running 0.36–0.54 m/s, measured and mapped across the entire work zone. A smoke study showing first air actually reaches the exposed vial — with the door open and an operator present — is mandatory.

Differential pressure cascade. Higher-grade zones must hold positive pressure relative to lower-grade ones. CPOB follows GMP practice of roughly 10–15 Pa between adjacent rooms of different grades. On site we design for 15–25 Pa, because filters load up over time and you want margin — a room that reads 11 Pa on day one is reading 8 Pa by month nine.

The cascade has to run the right direction: cleanest zone at the highest pressure, raw-material entry and waste exit at the lowest. We see projects fail this more than anything else.

Temperature and humidity. Usually 20–24 °C and 45–60 % RH, tuned to your product. Biological and aseptic filling areas often need tighter humidity control because of static and media growth.

HEPA integrity. Every terminal H14 gets a PAO/DOP leak test at qualification and is re-checked on schedule. A leak at the filter-to-ceiling seal — not the media itself — is the most common finding.

Air change and recovery. GMP does not mandate a specific number of air changes per hour. It mandates performance. Grade B rooms typically run 40–60 ACH, Grade C 20–40, Grade D 10–20. What inspectors actually want to see is the recovery test: after a deliberate particle challenge, the room returns to grade in 15–20 minutes.

Qualification before you make anything

BPOM expects the facility qualified before validation batches run: DQ (design), IQ (installation), OQ (operational), PQ (performance). PQ pulls together particle counts at rest and in operation, viable monitoring, airflow visualization (smoke), recovery time, and HEPA integrity.

This is where projects save or lose the most money. If you leave qualification until after construction finishes, a design mistake — say, a return grille sitting too close to the filling point and creating turbulence — means ripping out ceiling ductwork. The smoke study and layout review should happen at design stage, not at handover.After approval: it is not "done"

Once production starts, CPOB requires ongoing environmental monitoring: non-viable particle counts, viable air sampling, settle plates, surface contact plates, and personnel monitoring through gowning. You set alert and action limits from your own historical data, and every excursion triggers a documented investigation.Where Indonesian projects usually fail inspection

The repeat findings are rarely exotic. They look like this:

- Pressure cascade in the wrong direction, or drifting below minimum after a filter change.

- Gowning flow not staged — a single airlock instead of proper Grade C→B and B→A transitions.

- Smoke study missing, or only run in the "empty room" state rather than the operational state with doors open and operators present.

- Material and personnel paths crossing; waste leaving through the same corridor as raw material.

- HEPA leaks at the seal, not the media.

- Monitoring probes mounted on the ceiling but nowhere near the actual product exposure point.What if I am not making sterile products?

Oral solids, topicals, and non-sterile liquids do not need Grade A or B. CPOB generally requires a Grade D or controlled (pressurized, filtered, non-classified) environment, with dedicated dust control for high-drag steps like weighing and granulation. The grading is lighter, but the documentation — SOPs, monitoring records, qualification — still has to exist.Working on a CPOB cleanroom project?

Design, construction, and qualification are one continuous process. Doing them piecemeal — a design house here, a contractor there, a validation vendor brought in at the last minute — is exactly how projects miss the BPOM inspection window. OCCR delivers turnkey cleanroom EPC for pharmaceutical, biotech, vaccine, and IVD clients across Indonesia, from CPOB-aligned design through HVAC, enclosure, HEPA installation, and validation.

Read more about our cleanroom services, our design work, construction, and validation support. If you have a facility on the drawing board or a retrofitting project ahead, request a quote and we will review your layout against CPOB before construction starts.