Country guide: Indonesia
Cleanroom contractor in Indonesia: rules for buyers
In Indonesia BPOM approves drug factories under the CPOB standard and the Ministry of Health certifies device makers under CPAKB, so neither approves the contractor. A foreign construction firm must work through a representative office and a joint operation with a national contractor.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
PerBPOM 7/2025 amends the CPOB standard of PerBPOM 7/2024. It was signed on 4 March 2025 and promulgated on 20 March 2025 (BPOM, 2 May 2025). It restructures the annexes, clarifies sterile product requirements and adds quality risk management. It draws on the PIC/S GMP Guide and WHO guidelines.
Sterile product makers have up to 12 months to comply. Freeze-drying sites that load or unload without barrier or closed systems have up to 24 months (BPOM, 2 May 2025). BPOM joined PIC/S in July 2012 (PIC/S, checked 31 October 2026).
A medical device maker needs a CPAKB certificate and a manufacturing licence. Both are valid for five years and can be extended (Chambers Life Sciences 2026).
| Facility | Authority and rule |
|---|---|
| Drug factory | BPOM, PerBPOM 7/2024 (CPOB), amended by PerBPOM 7/2025 |
| Medical device factory | Ministry of Health, CPAKB certificate |
| Foreign contractor | PUPR, representative office (KP-BUJKA) and KSO |
Who builds cleanrooms here
Drug makers under CPOB and device makers under CPAKB are the regulated buyers. The 12-month and 24-month periods in PerBPOM 7/2025 apply to sterile and freeze-drying lines.
What a foreign contractor must arrange
The PUPR licensing portal lists Law 2/2017 on Construction Services and PUPR Regulation 6/2021 as the basis for a foreign firm's representative office. The foreign firm forms a KSO, a joint operation, with a national contractor for each construction activity. The partner must be a limited company with a large-qualification SBU in the same subclassification (PUPR portal, checked 31 October 2026).
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether CPOB or CPAKB applies. Name your national contractor if you already have one.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Which rule sets drug GMP in Indonesia?
PerBPOM 7/2024 on the CPOB standard, amended by PerBPOM 7/2025 (BPOM, 2 May 2025).
How long do sterile product makers have to comply?
Up to 12 months, and up to 24 months for some freeze-drying loading and unloading (BPOM, 2 May 2025).
Can a foreign contractor build alone in Indonesia?
No. It needs a representative office and a KSO with a national contractor (PUPR portal, checked 31 October 2026).
Is BPOM a PIC/S member?
Yes, since July 2012 (PIC/S, checked 31 October 2026).
Related guides
- How to audit a cleanroom panel factory, on site or by video
- How to Import a Cleanroom from China
- How to choose a cleanroom contractor: questions and evidence
- The Cleanroom Project Lifecycle
- Turnkey cleanroom contractor
- Room list builder
Sources
- BPOM, press release on the updated CPOB standard, PerBPOM 7/2025 (2 May 2025)
- PIC/S, list of participating authorities (Badan POM, PIC/S Scheme from July 2012; checked 31 October 2026)
- Chambers, Life Sciences 2026, Indonesia, CPAKB and manufacturing licence
- PUPR licensing portal, BUJKA (foreign construction business entity) (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184